Atralin .05 g/100g
Tretinoin · GEL · Bausch Health US, LLC
Atralin is a gel containing tretinoin at .05 g/100g, taken topical. Manufactured by Bausch Health US, LLC.
Key Facts
- Brand Name
- Atralin
- Generic Name
- Tretinoin
- NDC Code (Product)
13548-070- Manufacturer
- Bausch Health US, LLC
- Strength
- .05 g/100g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022070
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 07/26/2007
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 aw…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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. Selecte…
Frequently Asked Questions
What is Atralin used for?
Atralin contains Tretinoin. It is a gel taken topical. Consult your doctor for specific uses.
Is Atralin a controlled substance?
Atralin is not classified as a controlled substance by the DEA.
What is the generic name for Atralin?
The generic name for Atralin is Tretinoin. There are 12 other brand versions of Tretinoin.
What is the NDC code for Atralin .05 g/100g?
The NDC (National Drug Code) for Atralin .05 g/100g is 13548-070, listed by Bausch Health US, LLC.