Key facts
What is Atralin?
From the FDA label:Atralin (tretinoin) Gel, 0.05% is a translucent to opaque, pale yellow gel containing 0.05% tretinoin, by weight for topical administration. Chemically, tretinoin is all- trans -retinoic acid, also known as (all- E )-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds, and a metabolite of Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following structure: Each gram of Atralin Gel, 0.05% contains 0.5 mg of tretinoin. Other components of this formulation are benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine. The contribution to efficacy of individual components of the vehicle has not been evaluated. chem.jpg
How to use
For topical use only. Not for oral, ophthalmic, or intravaginal use. Atralin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy. Patients treated with Atralin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. When treating with Atralin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel has begun. • Apply a thin layer of Atralin Gel once daily, before bedtime, to skin where lesions occur. Keep away from eyes, mouth, nasal creases, and mucous membranes. ( 2 ) • Atralin Gel is not for oral, ophthalmic, or intravaginal use. ( 2 )
Side effects
The most common adverse reactions (incidence ≥5%) with Atralin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under prescribing conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14) ]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin…
Warnings
Important safety information
Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 ) • Topical over-the-counter acne preparations, concomitant topical medications, medicated cleansers, topical products with alcohol or astringents: Use with caution, irritation may occur. ( 5.1 ) • Avoid unprotected exposure to sunlight including sunlamps (UV light) when using Atralin Gel due to potential for increased photosensitization. Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) • Avoid use of Atralin Gel with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) • Use Atralin Gel with caution if allergic to fish due to potential for allergenicity to fish protein. Patients who develop pruritus or urticaria should contact their healthcare provider. ( 5.3 ) 5.1 Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. To help limit skin irritation, patients must: • wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, • avoid washing the treated skin too often and scrubbing the affected skin area, and • avoid contact with the peels of limes. 5.2 Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to tretinoin-treated skin. 5.3 Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their healthcare provider.
Who should not take Atralin
None. None ( 4 )
Drug class
How this class works, per Tretinoin - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Atralin ranks — best-rated retinoid for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Atralin treat?
- Atralin (Tretinoin) may be used to treat acne vulgaris, facial dermatoses, acute promyelocytic leukemia, hyperpigmentation, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Atralin work?
- Atralin is a retinoid. Retinoids are vitamin A derivatives that enter skin cells and switch on retinoic acid receptors in the nucleus, which changes how genes are read. This normalizes how skin cells grow and shed, unclogs pores, calms inflammation, and over time boosts collagen production.
- How much does Atralin cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.05 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Atralin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Atralin. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Atralin?
- Atralin is marketed by Dow Pharm. You can see Dow Pharm's full profile, rating, and other products on pharmaranks.
- Is Atralin a brand-name or generic drug?
- Atralin is a brand-name product with the active ingredient Tretinoin. Lower-cost generic equivalents containing Tretinoin are available — ask your pharmacist.
- Is Atralin available over the counter?
- No. Atralin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Atralin come in?
- Atralin is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Atralin?
- Atralin is classified as retinoid, per the FDA's Established Pharmacologic Class.
- Is Atralin FDA-registered?
- Atralin is on record with the U.S. FDA under application number NDA022070. You can verify this on its official FDA label.
- Is Atralin safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Atralin. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Atralin?
- Atralin's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (incidence ≥5%) with Atralin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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