Tacrolimus Ointment 0.1%
Tacrolimus Ointment 0.1%
Product Description
A prescription-strength topical calcineurin inhibitor (TCI) for the treatment of moderate to severe atopic dermatitis (eczema). This steroid-free immunomodulator reduces inflammation, itching, and redness by blocking calcineurin in the immune response, making it ideal for sensitive areas like the face and neck where corticosteroids may be inappropriate for long-term use.
โจ Texture & Feel
Calcineurin Inhibitor
Blocks calcineurin protein to reduce immune-mediated inflammation and suppress T-cell activation without the risks of topical steroids.
Steroid-Free Formula
Does not cause skin atrophy, thinning, or telangiectasia even with extended use, making it safe for sensitive facial areas.
Clinically Proven
Clinical trials show 73% of patients achieve 50%+ improvement. More effective than pimecrolimus with faster onset of action.
Anti-Malassezia Activity
Studies show tacrolimus has antifungal properties against Malassezia yeast species, potentially helping with seborrheic dermatitis.
๐ก๏ธ Safety & Compatibility
Limited data on topical use during pregnancy. Minimal systemic absorption expected, but consult your physician before use. Not recommended unless clearly necessary.
Low risk with topical application due to minimal absorption. Do not apply to breast/nipple area. Consult healthcare provider before use.
Safe for fungal acne. Research shows tacrolimus has antifungal activity against Malassezia species. Contains no fungal acne triggers.
While ointment base is occlusive, the formula is non-comedogenic. Petrolatum and mineral oil have comedogenic ratings of 0.
Rare reports of lymphoma and skin cancer in patients using TCIs. Causal link not established. Use only as directed for affected areas.
Common side effect: burning, stinging, itching at application site during first few days. Usually subsides as skin improves.
๐ฌ Ingredient Breakdown
๐ Tacrolimus 0.1% Active
A macrolide immunosuppressant originally derived from Streptomyces tsukubaensis bacteria. Works by inhibiting calcineurin, blocking T-cell activation and reducing inflammatory cytokines (IL-2, IL-3, IL-4, IFN-ฮณ, TNF).
- Mechanism: Binds to FKBP-12 protein, forming complex that inhibits calcineurin phosphatase activity
- Clinical Data: 37% achieve โฅ90% improvement; 73% achieve โฅ50% improvement in 12-week trials
- Absorption: Minimal systemic absorption (0.5% bioavailability); 85% of patients have blood levels <2 ng/mL
๐ข๏ธ White Petrolatum Vehicle
Highly purified occlusive emollient that creates a protective barrier on skin. Prevents transepidermal water loss (TEWL) and aids drug penetration.
- Function: Primary ointment base, provides occlusion and moisture retention
- Comedogenic Rating: 0 - does not clog pores despite occlusive nature
๐ง Mineral Oil Emollient
Highly refined petroleum-derived oil that softens and smooths skin. Acts as a carrier for tacrolimus and enhances spreadability.
- Grade: Pharmaceutical/cosmetic grade - highly purified
- Comedogenic Rating: 0 - non-comedogenic
๐งฑ Paraffin & White Wax Structure
Provides ointment consistency and stability. Creates smooth texture for even application and helps ointment adhere to skin.
๐ฌ Propylene Carbonate Solvent
Organic solvent that enhances tacrolimus solubility in the ointment base, ensuring uniform drug distribution and consistent dosing.
6 ingredients
Tacrolimus (0.1%), Mineral Oil, Paraffin, Propylene Carbonate, White Petrolatum, White Wax
๐ Where It Fits in Your Routine
Apply twice daily to affected areas only. Can use moisturizers after application. Avoid bathing/swimming immediately after.
๐ How to Use
Cleanse & Dry Completely
Wash affected areas gently with a mild cleanser. Pat skin completely dry before application - wet skin can dilute the medication.
Wash Hands
Wash hands thoroughly with soap and water before handling the medication to prevent contamination.
Apply Thin Layer
Apply a thin layer only to affected eczema areas. Use the minimum amount needed to cover the affected skin. Rub in gently and completely.
Wash Hands After
Unless treating your hands, wash hands immediately after application to avoid accidentally spreading to eyes or mouth.
Use Twice Daily
Apply at the same times each day (morning and evening). Stop when symptoms clear. Do not use continuously for extended periods.
๐ค Who Is It For?
โ Perfect for you if:
- You have moderate to severe atopic dermatitis
- Topical steroids haven't worked or aren't advisable
- You need treatment for face, eyelids, or neck
- You're concerned about skin thinning from steroids
- You need a steroid-sparing maintenance option
- You're 16 years or older (adults)
โ Consider alternatives if:
- You're pregnant or breastfeeding (consult doctor)
- You have a weakened immune system
- You have active skin infections (viral, bacterial, fungal)
- You're under 16 years old (use 0.03% strength)
- You're allergic to tacrolimus or any ingredients
- You have Netherton's syndrome or similar conditions
๐ฏ Skin Type Compatibility
Specifically designed for moderate to severe atopic dermatitis. Reduces inflammation, itching, and flares effectively.
Fragrance-free, minimal ingredients. Initial burning may occur but typically subsides. Safe for delicate facial skin.
Ointment base with petrolatum provides excellent occlusion and moisture retention. Helps repair barrier function.
Greasy ointment texture may feel heavy. Apply only to affected areas. Non-comedogenic despite occlusive feel.
Works well when applied only to eczema-affected areas. Avoid applying to non-affected oily zones.
Non-comedogenic formula. Has antifungal properties against Malassezia (fungal acne). Apply only to eczema areas.
๐ Results Timeline
Initial Application Phase
Common to experience burning, stinging, or itching at application sites. This is temporary and typically decreases as skin improves. Some early reduction in redness may begin.
70-80% experience burningEarly Improvement
Noticeable reduction in itching (pruritus) and inflammation. Burning sensation starts to diminish. Clinical trials show significant improvement in eczema severity scores.
50-60% notice improvementSignificant Clearing
Major improvement in redness, scaling, and skin thickness. Many patients see 50%+ improvement. Itching substantially reduced. Skin barrier begins to repair.
62-73% achieve 50%+ improvementOptimal Results
Maximum efficacy achieved. If no improvement by week 6, consult your physician for reassessment. Some patients achieve 90%+ clearance of symptoms.
27-37% achieve 90%+ clearanceโญ Ratings by Platform
โ๏ธ Pros & Cons
โ Praised
- Highly effective for moderate-severe eczema
- Steroid-free - no skin thinning risk
- Safe for face, eyelids, and sensitive areas
- Clears stubborn eczema that steroids couldn't
- "Life-changing" for facial eczema sufferers
- Fast improvement within 1-2 weeks
- Can use long-term with intermittent breaks
- Fragrance-free, minimal ingredients
โ Criticized
- Intense burning/stinging during first days
- Greasy ointment texture
- Expensive without insurance
- Requires prescription
- Black box warning causes concern
- Cannot use with alcohol (flushing)
- Increased sun sensitivity
- Not for children under 16 (0.1% strength)
๐ฐ Alternative Treatment Options
Identical active ingredient (tacrolimus 0.1%) from original manufacturer Astellas. Same efficacy, same side effects. Glenmark is the FDA-approved generic equivalent at lower cost.
Another calcineurin inhibitor but for MILD-MODERATE eczema only. Cream vehicle less greasy. Studies show tacrolimus 0.1% is more effective with faster onset. Less burning reported.
PDE4 inhibitor (different mechanism). For mild-moderate eczema. No black box warning. Can use in children 3+ months. Higher rates of stinging reported. Less potent than tacrolimus.
Newer JAK inhibitor topical. For mild-moderate atopic dermatitis. Different mechanism targeting JAK pathway. Very expensive. For patients who failed other treatments.
๐ Comparison with Competitors
Glenmark Tacrolimus 0.1% (This Product)
$$Elidel (Pimecrolimus) 1%
$$Eucrisa (Crisaborole) 2%
$$$Topical Corticosteroids
$๐ฆ Storage & Shelf Life
12 months after opening. Check expiration date on packaging.
Store at room temperature 68-77ยฐF (20-25ยฐC). Keep away from heat and direct light. Do not freeze. Do not leave in car.
Laminated aluminum tube with screw cap. Keep cap tightly closed when not in use.
Yes, 30g and 60g tubes are under 100ml. Store upright in carry-on. Avoid extreme temperatures during transport.
โ Frequently Asked Questions
Pregnancy: Use with caution. There is limited data on topical tacrolimus use during pregnancy. Systemic absorption is minimal (approximately 0.5%), but the available studies are insufficient to rule out all risks. Consult your physician before use - it should only be used if the potential benefit justifies the potential risk to the fetus.
Breastfeeding: Low risk with topical use. While tacrolimus is excreted in breast milk when taken orally, topical application results in very low blood levels. Do not apply to the breast/nipple area. Monitor the infant if used during breastfeeding. Some guidelines allow use with caution.
Yes, it is safe and may even help! Scientific studies show tacrolimus has antifungal activity against Malassezia species. Research published in Clinical Drug Investigation demonstrated that tacrolimus inhibits growth of Malassezia furfur at concentrations of 0.5-32 mg/L, with fungicidal effects. The simple ointment base contains no ferments, fatty acids, esters, or polysorbates that feed Malassezia. Tacrolimus may actually help reduce Malassezia colonization on the skin.
Use with caution or avoid during active treatment. Tacrolimus is designed for eczema-affected skin, which is already compromised. Adding irritating actives like retinol, vitamin C (ascorbic acid), or acids (AHA/BHA) can increase burning, irritation, and potentially worsen your condition. Wait until eczema is controlled and skin barrier is repaired before reintroducing these ingredients. If you must use them, apply to non-affected areas only. Consult your dermatologist about timing.
Best for: Patients with moderate to severe atopic dermatitis (eczema), especially those with dry, sensitive, or eczema-prone skin. The ointment base provides excellent occlusion for very dry skin. Ideal for sensitive areas like face, eyelids, and neck where steroids are not advisable.
May not suit: Very oily skin types may find the greasy texture uncomfortable. However, since it's only applied to affected eczema areas (not the whole face), even oily-skinned patients can use it. The formula is non-comedogenic despite its occlusive nature.
Week 1: Initial improvement in itching and some reduction in redness. Burning sensation typically decreases.
Weeks 2-4: Significant improvement - clinical trials show 62-73% of patients achieve 50% or better improvement.
Week 6: Maximum effect should be reached. If no improvement by this point, consult your doctor for reassessment.
Note: Some patients see dramatic improvement within the first week, while others take the full 6 weeks. Continue treatment as directed even if initial burning occurs.
Application order:
1. Cleanse skin gently with mild cleanser
2. Pat completely dry (important!)
3. Apply thin layer of Tacrolimus to affected areas ONLY
4. Wait 15-30 minutes
5. Apply moisturizer if desired
6. Apply sunscreen in morning (medication increases sun sensitivity)
Important: Apply to DRY skin only. Do not bathe, shower, or swim immediately after application. Can use moisturizers but wait until tacrolimus has absorbed.
Non-comedogenic. Despite the ointment's greasy, occlusive texture, the ingredients have a comedogenic rating of 0. White petrolatum and mineral oil (the main base ingredients) do not clog pores. The formula contains no known comedogenic ingredients. However, you should only apply to eczema-affected areas, not your entire face. This medication is for treating eczema, not for general skincare use.
12 months after opening. Always check the expiration date printed on the tube and packaging. Store at room temperature (68-77ยฐF / 20-25ยฐC), away from heat and direct sunlight. Do not freeze. Keep the tube tightly closed when not in use. Do not use if the ointment has changed color, consistency, or smell. Discard properly after the expiration date or 12 months after opening, whichever comes first.
The burning/stinging sensation is the most common side effect, experienced by 40-70% of patients. It's caused by tacrolimus interacting with nerve endings in inflamed skin. Key points:
โข Most intense during first 1-3 days
โข Typically starts 10-60 minutes after application
โข Can last 30 minutes to several hours
โข Decreases as eczema improves and skin barrier repairs
โข Usually gone after 1-2 weeks of consistent use
โข Worse with more severe eczema and facial application
โข Applying to wet skin or using too much increases burning
Tips to reduce burning: Apply to completely dry skin, use a thin layer, avoid immediately before bedtime if it keeps you awake, and be patient - most patients find it manageable after the first few days.
0.1% (This product): Higher concentration, approved for adults and teens 16+ years old. More effective for moderate to severe eczema. Clinical studies show better results than 0.03% especially for severe cases.
0.03%: Lower concentration, approved for adults AND children ages 2-15 years. Used for pediatric patients and adults with milder symptoms or who cannot tolerate the higher strength.
Both concentrations have the same mechanism of action - the difference is in potency. Your dermatologist will prescribe the appropriate strength based on your age, disease severity, and treatment response.
Verdict: Tacrolimus Ointment 0.1% is a highly effective, clinically-proven treatment for moderate to severe atopic dermatitis. As a steroid-free calcineurin inhibitor, it's invaluable for long-term management and for treating sensitive areas like the face and eyelids where topical steroids can cause thinning. Clinical trials demonstrate impressive efficacy with 73% of patients achieving significant improvement. The main drawback is the burning sensation during initial use, which deters some patients but typically resolves within 1-2 weeks. The generic Glenmark version provides the same FDA-approved formulation at a lower cost than brand-name Protopic. Recommended for: Adults with stubborn eczema, facial/eyelid eczema, steroid-induced skin thinning, or those needing a steroid-sparing maintenance option. Note: This is a prescription medication - consult your dermatologist to determine if it's right for you.
Product Overview
What are Quick Product Notes?
Quick product notes are a great way to check if a product is free from commonly avoided ingredients by skincare enthusiasts. These preferences come about for different reasons depending on the ingredient such as personal experiences, sensitivities, health preferences & etc.
Pro Tip Alert!
Just because a product is not free from a common preference does not mean it's a bad product! You can make a personal decision whether or not you want to use a product that contains these ingredients or not - click the labels of the preference to read more about them.
Quick Product Notes
Paraben-Free
Paraben-Free
Understanding Parabens
Parabens are a large group of preservatives which are used to prevent bacteria growing in cosmetic formulations. There has been some healthy controversy surrounding them due to a few studies finding paraben presence in breast tumours and breast tissue. However, the majority of the scientific community have deemed these findings non-conclusive due to the limitations of these studies. There's still a lot of support for avoiding parabens following the better safe than sorry route. If you do we completely support you! If you are concerned about the health safety of parabens, then feel free to avoid them by looking out for the Paraben-Free icon. If not, don't worry about it - they do have had one of the longest safety records as preservatives!
Which Ingredients are classified as Paraben?
A product will be paraben-free if it does not contain any of the following parabens:
- Sodium Isobutylparaben
- Sodium Ethylparaben
- Sodium Butylparaben
- Propylparaben
- Isopropylparaben
- Isobutylparaben
- Sodium Propylparaben
- Butylparaben
- Ethylparaben
- Sodium Methylparaben
- Methylparaben
Sulfate-Free
Sulfate-Free
Understanding Sulfates
Sulfates are a large group of ingredients which act as cleansing agents in Cosmetics. They help loosen up the dirt and grime from your skin and hair to allow for water to wash it away with ease. However some sulfates are so good at their job, they can wash off your skinโs own natural oils that keep it moisturised and protected which can lead to dryness and irritation. Most people will find no issues with sulfate, however if you find your skin doesn't like sulfates then free feel to avoid them by looking out for the sulfate-free icon on Skincarisma.
Which ingredients are classified as sulfates?
We've taken the Sulfates which are considered more harsh for our Sulfate-Free status. A product will be Sulfate-Free if it does not contain any of the following Sulfates:
- TEA-Dodecylbenzenesulfonate
- Ammonium Laureth Sulfate
- Sodium Lauryl Sulfate
- PEG-15 Cocamine
- Sodium Laureth Sulfate
- Sodium Cocoyl Sarcosinate
- Sodium C14-16 Olefin Sulfonate
- Dioctyl Sodium Sulfosuccinate
- Ammonium Xylenesulfonate
- Ammonium Lauryl Sulfate
- Sodium Xylenesulfonate
- Sodium Myreth Sulfate
- Sodium Lauryl Sulfoacetate
Alcohol-Free
Alcohol-Free
Understanding Simple Alcohols
Alcohol ingredients are widely used in cosmetics and come in different types. For the most part alcohols are not problematic at all. However one type of alcohols, simple alcohols can be quite drying to the skin because it evaporates very quickly. This can cause irritation which can also lead to other skin complications. These alcohols should never be used alone on your skin, but combined with other cosmetic ingredients, they are normally without issue. However, for some people with sensitive and easily irritable skin, avoiding products with these simple alcohols may be beneficial. If you find your skin doesn't like these simple alcohols, then free feel to avoid them by looking out for the Alcohol-Free icon.
Which Ingredients are classified as Alcohol?
A product will be alcohol-free if it does not contain any of the following alcohol ingredients:
- SD Alcohol
- Alcohol Denat
- Isopropyl Alcohol
- Alcohol
Silicone-Free
Silicone-Free
Understanding Silicones
If you've ever used a skincare, makeup or beauty product that's made your skin look and feel smoother tempoarily - it's likely contained Silicone. They are a popular class of ingredients found in cosmetics due to their smooth, soft, easy-to-spread and smooth properties that help creates an artificial layer/barrier on top of skin or hair (commonly found in conditioners).
For the same reasons they are popularly used, they are also commonly avoided. Anecdotally, many individuals have reported that Silicones cause/excerbate breakouts, irritation, cause a feeling of skin being unable to breathe, cause clumping of cosmetic products and find it difficult to wash off. As a result, those who find them problematic are avoiding them and increasingly, cosmetic companies are avoiding them as well.
If you have had bad experiences with Silicones in the past, or suspect they are problematic then look out for the tick on the Silicone-free label.
Disclaimer
The Silicone-free label only includes the most common Silicone ingredients that have indentified been reported by individuals that could potentially cause issues.
These include: Amodimethicone, Behenoxy Dimethicone, Bis-Aminopropyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Cyclomethicone, Cyclopentasiloxane, Dimethicone, Dimethicone Copolyol, Dimethiconol, Methicone, Phenyl Trimethicone, Phenyl Trimethicone, Stearoxy Dimethicone, Stearyl Dimethicone, Trimethylsilylamodimethicone.
Note, that this does not include all ingredients part of the Silicone class of ingredients.
EU Allergen-Free
EU Allergen-Free
Understanding the Identified Contact Allergens
The EU's Scientific Committee on Consumer Safety (SCCS) has identified and established 26 cosmetic ingredients that are likely contact allergens (potential to cause skin allergies) as demonstrated in clinical or epidemiological studies. The EU's SCCS have recommend cosmetic companies to disclose them on the labels if used and in cases where the concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products, then they must be labelled.
Look out for the tick on the EU-Allergen free label to know your cosmetic is free from any of the 26 identified cosmetic ingredients.
For more information regarding the EU's Scientific Committee on Consumer Safety, please visit their official website.
Disclaimer
The EU Allergen Free label is for the 26 ingredients identified by the EU SCCS and products will be only flagged if a suspected ingredient is on it's ingredient list. It is possible for cosmetics to contain one of the suspect ingredients without it appearing on the ingredient list due to it not reaching the concentration threshold to disclose it and cosmetic manufacturers choice to not disclose it.
Also note, the EU Allergen Free label is not personalized for your own allergies you may have and it does not constitute as medical advice. For your specific case, always consult your medical professiona such as dermatologist, physician, pharmacist, or health care provider - please read our medical disclaimer for more information.
Fungal Acne (Molassezia) Safe
Fungal Acne (Molassezia) Safe
Understanding Fungal Acne (Pityrosporum Folliculitis/Malassezia Folliculitis)
Pityrosporum Folliculitis/Malassezia folliculitis or simply known as Fungal Acne is a persistent acne-like condition that commonly responds poorly to traditional acne-treating methods. Unlike most cases of Acne where bacteria is the culprit, Fungi is the culprit of Fungal Acne (Hence the name!). There are certain classes & groups of ingredients that have been shown to promote and feed the growth of the Fungal Acne, Fungi such as fatty acids, oils, esters, polysorbates and fermented ingredients.
For more information regarding Fungal Acne, please visit Simple Skincare Science (f.c) - #3 of our Recommend Skincare Resources for an amazing comprehensive guide!
Please Read: How to use the Fungal Acne (Malassezia) Label
At SkinCarisma, we've done our best to identify as many ingredients as possible but note the fungal-free label may not be 100% accurate due to the complexconditions and combination of ingredients that malezzeria can thrive on.
Additionally, products that may contain ingredients that have shown to feed Malassezia may not neccessarily exacerbate the condition due to concentration of ingredient used in the product, this information is simply not available on the products.
As a result, please note this is only an experimental label that can be best used to possible identify problematic products you have used in the past. It is in no way a perfect identifier nor a predictor in whether or not it will exacerbate or cause fungal acne. It will continue to be worked on as more information and research comes to light.
If you find any ingredients you believe should be included, please email us at snails@skincarisma.com.
Disclaimer
Due to the lack of substantial research into this area it is very likely there are other ingredients and class/groups of ingredients that could feed Fungal Acne which have not been indentified.
The Fungal-Safe label does not constitute as medical advice. For your specific case, always consult your medical professiona such as dermatologist, physician, pharmacist, or health care provider - please read our medical disclaimer for more information.
What are Notable Effects & Ingredients?
Ever used a product that promised a certain effect but provided no results? It might not have contained any notable ingredients that could have been responsible for that promised effect. It doesn't matter what the marketing or packaging ยซpromisesยป it can do, if it doesn't contain anything that can help - then the likelihood of it helping is low.
We help you identify key notable ingredients that have been shown to help with effects such as acne-fighting, brightening, UV-protection, wound healing & anti-aging to help you achieve your skincare goals smarter. Please note that different notable ingredients have varying levels of research behind them, some are extremely well proven yet some have mixed research in their efficacy.
Pro Tip Alert!
Just because a product doesn't contain any notable ingredients doesn't mean it's bad. And a product with notable ingredients (or even many) doesn't necessarily guarantee the efficacy of the product performing these effects either. There are other factors such as ingredient quality, concentration and formulation that will ultimately determine this.
Be smart and use this as just a starting point for you to make more informed and smarter choices and compare it with reviews to see if the product is right for you
Notable Effects & Ingredients
What are Ingredients Related to Skin Type?
Why are some products great for some people and horrible for others? Well everyone has different skin types and different reactions to the same ingredients.
We've identified a range of ingredients that are commonly regarded as potentially good or bad for those with Dry, Oily/Acne-Prone or Sensitive skin.
Pro Tip Alert!
A product that contains good or bad ingredients for your skin type doesn't always flat out make the entire product good or bad for your skin. There are other factors such as ingredient quality, concentration and formulation that will ultimately determine your skins reaction.
One of the best ways to use this section is to troubleshoot products you've had bad experiences with in the past. Check if it contains any of the marked ingredients to point out suspect ingredients to avoid in the future!
Ingredients Related to Skin Types
Dry Skin
Oily/Acne-Prone Skin
Sensitive Skin
What is the Ingredient Safety Breakdown?
Ingredient Safety Breakdown refers to the percentage % of ingredients in different risk categories as classified by EWG (Environment Working Group) if they are available. There are almost endless cosmetic ingredients and they are one of the few organisations globally that have assigned ratings to a lot of the more commonly used ingredients which is why we reference them.
Pro Tip Alert!
EWG is seen by many to be more on the alarmist side in their assignment of health ratings resulting in rating ingredients as riskier than they actually are. We recommend using this a reference point rather than a strict guide of ingredient safety and to always do further research if into ingredients that you may find suspect.
Ingredient Safety Breakdown
Product ingredient list
| EWG | CIR | Ingredient Name & Cosmetic Functions | Notes |
|---|---|---|---|
| 0 |
Limus
Skin Conditioning
|
|
|
| 0 |
Paraffinum Liquidum
Emollient, Skin Protecting, Solvent
|
|
|
| 1 |
Paraffin
Emollient, Fragrance, Viscosity Controlling, Viscosity Increasing Agent, Skin-Conditioning Agent - Occlusive
|
|
|
| 1 |
Propylene Carbonate
Solvent, Viscosity Controlling, Viscosity Decreasing Agent
|
|
|
| 4 |
Petrolatum
Emollient, Hair Conditioning, Skin Protecting, Uv Absorber, Moisturising, Skin-Conditioning Agent - Occlusive
|
|