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Tacrolimus Ointment 0.1%

Tacrolimus Ointment 0.1%

Product Description

Glenmark Pharma Tacrolimus Ointment 0.1% is a prescription-strength, steroid-free topical treatment for moderate-to-severe atopic dermatitis (eczema). As a topical calcineurin inhibitor, it calms the overactive immune response that drives eczema flares โ€” and because it doesn't thin the skin like steroids, it is often chosen for delicate areas such as the face and eyelids. It is a second-line therapy intended for use under a doctor's supervision when other prescription treatments have failed or are not advisable. Prescription only (Rx).

๐Ÿ‡ฎ๐Ÿ‡ณ Prescription Dermatology ยท Generic (Glenmark Pharma) ยท Made in India
โœ” Prescription Only (Rx) โœ” Steroid-Free โœ” Topical Calcineurin Inhibitor โœ” FDA-Approved Generic โœ” Fragrance-Free โœ” For Eczema / Atopic Dermatitis
Pregnancy Safe
Caution โš ๏ธ
Use on Infected Skin
No โš ๏ธ
Comedogenic Rating
1/5
๐Ÿ’Š
Type
Calcineurin Inhibitor
๐Ÿงช
Active
Tacrolimus 0.1%
๐ŸŽฏ
Treats
Atopic Dermatitis
๐Ÿšซ
Steroid
Steroid-Free
๐Ÿ“‹
Status
Prescription (Rx)

โœจ Texture & Feel

๐Ÿ’ง
Consistency
Ointment (petrolatum)
๐Ÿ‘ƒ
Scent
Fragrance-free
โฑ๏ธ
Absorption
Slow / occlusive
๐ŸŽฏ
Finish
Greasy / emollient
๐Ÿงฌ

Targets the Cause of Flares

Blocks calcineurin to calm the overactive T-cells that drive eczema inflammation, rather than only soothing symptoms on the surface.

๐Ÿšซ

Steroid-Free

No risk of skin thinning (atrophy), so under medical guidance it can be used on delicate areas like the face and eyelids where long-term steroids aren't advisable.

๐Ÿ”

Bioequivalent Generic

Glenmark's formulation was studied for therapeutic equivalence to the brand Protopic 0.1% in moderate-to-severe atopic dermatitis.

โš•๏ธ

Second-Line Therapy

Indicated when other prescription treatments have failed or are not advisable. Designed for short-term and intermittent use under a doctor's care.

๐Ÿ›ก๏ธ Safety & Compatibility

โš ๏ธ
FDA Boxed Warning

Rare cases of skin cancer and lymphoma have been reported with topical calcineurin inhibitors. A causal link is not established, but use only as prescribed โ€” a thin layer, short-term, and not continuously over the long term.

๐Ÿคฐ
Pregnancy & Breastfeeding

Topical absorption is low, but use only if clearly needed and approved by your doctor. Do not apply to the breast area while nursing.

๐Ÿฆ 
Not for Infected Skin

Do not apply over active bacterial, viral (e.g. cold sores, chickenpox) or fungal skin infections, as it suppresses the local immune response.

โ˜€๏ธ
Sun & Alcohol

Minimize sunlight and UV exposure during treatment. Burning, itching or facial flushing (especially after alcohol) is common, particularly in the first few days.

โœ…
No Skin Thinning

Unlike topical steroids, it does not cause skin atrophy, making it suitable for thin and delicate skin under medical guidance.

โš•๏ธ
Prescription Only ยท Age 2+

Requires a prescription. The 0.1% strength is for adults and adolescents 16+; it is not for children under 2. Immunocompromised patients should not use it.

๐Ÿ”ฌ Ingredient Breakdown

๐Ÿงฌ Tacrolimus (Limus) 0.1% Proven

The active ingredient โ€” a topical calcineurin inhibitor. It binds the protein FKBP-12 and blocks calcineurin, which stops the T-cell activation and cytokine release that fuel eczema inflammation.

  • FDA: Approved as second-line therapy for moderate-to-severe atopic dermatitis.
  • Clinical study: Glenmark's 0.1% generic was evaluated for therapeutic equivalence to Protopic 0.1%.
  • Evidence reviews: Found 0.1% effective for eczema, with no clear evidence of increased skin-cancer or skin-thinning risk, though long-term data remain limited.
โš ๏ธ
Carries an FDA boxed warning regarding rare reports of malignancy. Use only as directed by a doctor.

๐Ÿ›ก๏ธ White Petrolatum & Paraffin Base Occlusive

The anhydrous ointment base. These occlusive emollients seal in moisture and carry the active into the skin, supporting a damaged eczema barrier.

  • Function: Vehicle, emollient and occlusive.
  • Note: Petrolatum rates low on the comedogenic scale, but feels greasy on the skin.

๐Ÿ’ง Paraffinum Liquidum (Mineral Oil) Base Emollient

Light mineral oil that softens the ointment and helps spread the active evenly across affected skin.

  • Function: Emollient and solvent within the base.

โš—๏ธ Propylene Carbonate Solvent Carrier

A solvent that helps dissolve and stabilise tacrolimus within the ointment so the active is delivered consistently.

  • Function: Solvent and penetration carrier.

6 ingredients

Active: Tacrolimus (Limus) 0.1%. Inactive: Paraffinum Liquidum (Mineral Oil), Paraffin, Propylene Carbonate, Petrolatum (White Petrolatum), White Wax. (The SkinSort listing for this item also references "Palau White Clay"; the FDA-approved formula lists white wax.)

FREE FROM: Corticosteroids (steroid-free), added fragrance, dyes, parabens, water (anhydrous formula).

๐Ÿ”„ Where It Fits in Your Routine

1
Gentle Cleanse
2
Pat Fully Dry
3
Tacrolimus 0.1%
4
Let Absorb
5
Emollient
6
SPF (Daytime)

Apply a thin layer to affected skin only, twice daily. Wash your hands afterward (unless treating the hands), let it absorb before layering an emollient, and always use daily sun protection โ€” this medicine increases sun sensitivity.

๐Ÿ“ How to Use

1

Cleanse & Dry

Wash the affected area with a gentle cleanser and pat it completely dry before applying.

2

Apply a Thin Layer

Apply twice daily to affected skin only โ€” not to healthy skin. Use the smallest amount that covers the area.

3

Rub In & Wash Hands

Rub in gently and completely, then wash your hands โ€” unless your hands are the area being treated.

4

Protect From Sun

Avoid prolonged sunlight, sunlamps and tanning beds. A temporary burning or itching sensation in the first days is common.

5

Reassess at 6 Weeks

Stop when symptoms clear and do not use continuously long-term. If there's no improvement after 6 weeks, see your doctor.

๐Ÿ‘ค Who Is It For?

โœ… Perfect for you if:

  • You have moderate-to-severe eczema that hasn't responded to other prescription treatments
  • You need a steroid-free option for the face, eyelids or skin folds
  • You want to avoid the skin-thinning risk of long-term topical steroids
  • You're an adult or adolescent diagnosed by a clinician (0.1% strength)

โŒ Consider alternatives if:

  • You have a weakened immune system
  • The area has an active bacterial, viral or fungal infection
  • You're under 2 years old (not approved)
  • You're pregnant or breastfeeding without doctor approval
  • You're looking for an over-the-counter cosmetic โ€” this is prescription only

๐ŸŽฏ Skin Type Compatibility

Atopic / Eczema-Prone โ˜…โ˜…โ˜…โ˜…โ˜… Excellent

Its core indication โ€” calms the inflammation that drives eczema flares at the source.

Facial & Eyelid Skin โ˜…โ˜…โ˜…โ˜…โ˜… Excellent

Steroid-free, so it suits thin, delicate areas where long-term steroids are risky.

Sensitive Skin โ˜…โ˜…โ˜…โ˜†โ˜† Moderate

Effective, but a transient burning or stinging sensation is common in the first few days.

Active Skin Infection โ˜…โ˜†โ˜†โ˜†โ˜† Poor

Contraindicated over active bacterial, viral or fungal infections.

Healthy Skin (Cosmetic Use) โ˜…โ˜†โ˜†โ˜†โ˜† Poor

Not a cosmetic โ€” it is a prescription medicine for diagnosed eczema only.

๐Ÿ“ˆ Results Timeline

First Few Days

Application-Site Reaction

Warmth, burning, itching or flushing where applied is the most common early effect, and is usually temporary.

Most common early effect
Within 1 Week

Early Relief

Many users report visibly reduced redness and itch within days as the burning sensation settles.

56% report positive results (Drugs.com)
1โ€“6 Weeks

Clearance for Responders

Inflammation and itch often resolve over several weeks. Reassess with your doctor at 6 weeks if there's no improvement.

Stop use when clear

โญ Ratings by Platform

๐ŸŒฟ Drugs.com
โ˜…โ˜…โ˜…โ˜† 6.5/10
Rating
123
Reviews (Eczema)
โš ๏ธ Main complaint: Intense burning or stinging during the first applications.
๐ŸŒฟ WebMD
โ˜…โ˜…โ˜…โ˜† Mostly +
Sentiment
Patient
Reports
โš ๏ธ Main complaint: Skin feels hot or flushed for an hour or so after applying.
๐Ÿ  FDA / Clinical Record
Bioequivalent
vs Protopic
Approved
FDA Status
โš ๏ธ Main caveat: Intended for short-term, non-continuous use โ€” not daily long-term.

โš–๏ธ Pros & Cons

โœ… Praised

  • Steroid-free โ€” no skin thinning, suitable for face and eyelids under guidance
  • Effective on stubborn eczema that steroids couldn't control
  • Works quickly for many users (often within days)
  • Generic โ€” typically far cheaper than brand-name Protopic

โŒ Criticized

  • Burning or stinging in the first days is very common
  • Prescription required โ€” not available over the counter
  • Carries an FDA boxed warning (rare malignancy reports)
  • Increases sun sensitivity; alcohol can trigger flushing
  • Greasy ointment texture; not for infected skin or under-2s

๐Ÿ’ฐ Therapeutic Alternatives (Prescription Required)

90% Match
Pimecrolimus 1% Cream (Elidel)
Rx ยท varies Same Class

The other topical calcineurin inhibitor. A lighter cream that often causes less burning, but is generally used for mild-to-moderate eczema. Requires a prescription and a doctor's guidance.

70% Match
Crisaborole 2% Ointment (Eucrisa)
Rx ยท varies Steroid-Free

A steroid-free PDE4 inhibitor for mild-to-moderate eczema. Different mechanism and no boxed warning, but generally less potent for severe cases. Prescription required.

65% Match
Topical Corticosteroids (e.g. Mometasone)
Rx / OTC First-Line

Fast and widely used as first-line therapy, but carry a risk of skin thinning with long-term use, especially on the face. Not interchangeable โ€” use only under medical guidance.

๐Ÿ”„ Comparison with Competitors

Protopic 0.1% (Brand)

Rx ยท Brand
Active Ingredient Tacrolimus 0.1%
Steroid-Free Yes
Price Higher than generic
Status Prescription

Elidel (Pimecrolimus 1%)

Rx
Active Ingredient Pimecrolimus 1%
Steroid-Free Yes
Strength Milder
Best For Mildโ€“moderate eczema

Topical Corticosteroid

Rx / OTC
Active Ingredient Corticosteroid
Steroid-Free No
Skin-Thinning Risk Yes (long-term)
Speed Fast

๐Ÿ“ฆ Storage & Shelf Life

๐Ÿ“…
Period After Opening (PAO)

12 months โ€” but always follow the expiry/discard date printed on the tube and carton.

๐Ÿ 
Storage

Store at room temperature (15โ€“30ยฐC / 59โ€“86ยฐF), away from heat. Keep the tube tightly closed and out of children's reach.

๐Ÿ“ฆ
Packaging

Sealed laminate/aluminium tube (commonly 10g, 30g or 60g).

โœˆ๏ธ
Travel Friendly

Yes โ€” compact tube. Carry it in its labeled box with the prescription.

โ“ Frequently Asked Questions

Caution. Absorption through the skin is low, but it should be used during pregnancy only if your doctor decides the benefit outweighs the risk โ€” systemic tacrolimus has been linked to newborn issues. While breastfeeding, do not apply it to the breast area. Always confirm with your doctor before use.

This is a prescription eczema medicine rather than a cosmetic, so the "fungal-acne-safe" framework doesn't really apply. More importantly, it must not be used on skin with an active fungal (or bacterial/viral) infection, because it suppresses the local immune response. If you suspect any skin infection, speak to your doctor first.

There's no formal cosmetic-layering guidance because it's a medication, not a serum. Don't combine other actives on the same treated area without your doctor's advice โ€” irritation can worsen the burning sensation. Apply tacrolimus to affected skin only, and keep harsh actives away from those areas.

It's best for people with diagnosed moderate-to-severe atopic dermatitis (eczema) โ€” especially on the face and eyelids โ€” who haven't responded adequately to other treatments. It is not intended for healthy skin or cosmetic use.

Many people notice reduced itch and redness within the first week, with fuller improvement over 1โ€“6 weeks. If there's no improvement after 6 weeks, see your doctor to reconfirm the diagnosis. A temporary burning sensation early on is common and usually settles.

After cleansing and drying, use it as a treatment step on affected areas only, twice daily. Wash your hands afterward, let it absorb before applying an emollient, and use SPF during the day since it increases sun sensitivity.

The petrolatum-based vehicle is low on the comedogenic scale (about 1/5), so clogging is not a primary concern. That said, this is a medicine for eczema, not a moisturiser โ€” use it only on affected skin as prescribed, not all over the face.

Follow the discard/expiry date printed on the tube and carton โ€” commonly within about 12 months. Store it at room temperature with the tube tightly closed, and do not use it past its expiry date.

โ˜…โ˜…โ˜…โ˜…โ˜†
4.0 out of 5

Verdict: For the right candidate โ€” someone with stubborn, steroid-resistant or facial eczema โ€” Glenmark Pharma's Tacrolimus Ointment 0.1% is a genuinely valuable, steroid-free option that treats the cause of flares without thinning the skin. Patient ratings are solid but mixed (around 6.5/10 on Drugs.com), largely because of the temporary burning many people feel in the first few days. It is a prescription medicine with an FDA boxed warning, so it should be used only under a doctor's guidance โ€” short-term and on affected skin, not as an everyday cosmetic.

Product Overview

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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.

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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.

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Quick Product Notes

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lightbulb 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.

muscle 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

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Notable Effects & Ingredients

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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.

muscle 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!

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Ingredients Related to Skin Types

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dry-skin Dry Skin
oily-skin Oily/Acne-Prone Skin
sensitive-skin Sensitive Skin
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lightbulb 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.

muscle 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.

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Ingredient Safety Breakdown

EWG Health Ratings
Low risk
Medium risk
High risk
Unknown risk
33% 16% 50%

Product ingredient list

Showing first 5 of 6 ingredients
EWG CIR Ingredient Name & Cosmetic Functions Notes
0 Unknown
Limus
Skin Conditioning
0 Unknown
Paraffinum Liquidum
Emollient, Skin Protecting, Solvent
1 A
Paraffin
Emollient, Fragrance, Viscosity Controlling, Viscosity Increasing Agent, Skin-Conditioning Agent - Occlusive
1 A
Propylene Carbonate
Solvent, Viscosity Controlling, Viscosity Decreasing Agent
4 Unknown
Petrolatum
Emollient, Hair Conditioning, Skin Protecting, Uv Absorber, Moisturising, Skin-Conditioning Agent - Occlusive
VIEW ALL INGREDIENTS