Retin-A .1 mg/g
Tretinoin · GEL · Bausch Health US, LLC
Retin-A is a prescription topical gel containing tretinoin, a retinoid medication commonly used to treat acne and reduce signs of aging on the skin. It works by promoting skin cell turnover and is applied directly to affected areas of the skin.
Key Facts
- Brand Name
- Retin-A
- Generic Name
- Tretinoin
- NDC Code (Product)
0187-5172- Manufacturer
- Bausch Health US, LLC
- Strength
- .1 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA017955
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 07/30/1979
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. • Prior to RETIN-A MICRO use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry. • When applying RETIN-A MICRO, keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Apply a thin layer of RETIN-A MICRO (0.04%, 0.06%, 0.08%, or 0.1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening. Do not apply more than a thin layer [see Warning and Precautions (5.1) ] . Improvements in acne lesions may be noticed after two weeks of RETIN-A MICRO therapy, but more than seven weeks of therapy may be needed for sustained benefit. If RETIN-A MICRO was temporarily discontinued due to local adverse reactions, RETIN-A MICRO therapy may be resumed upon resolution of local adverse reactions. • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) • Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes. ( 2 ) • Apply a thin layer of RETIN-A MICRO to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.06%, 0.08%, or 0.1%) once da…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis. (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 widely varying 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. RETIN-A MICRO, 0.1% The safety of RETIN-A MICRO, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2). A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received RETIN-A MICRO, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-40) and 55% were female [see Clinical Studies (14.1) ] . RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age [see Indications and U…
Frequently Asked Questions
What is Retin-A used for?
Retin-A is a prescription topical gel containing tretinoin, a retinoid medication commonly used to treat acne and reduce signs of aging on the skin. It works by promoting skin cell turnover and is applied directly to affected areas of the skin.
Is Retin-A a controlled substance?
Retin-A is not classified as a controlled substance by the DEA.
What is the generic name for Retin-A?
The generic name for Retin-A is Tretinoin. There are 10 other brand versions of Tretinoin.
What is the NDC code for Retin-A .1 mg/g?
The NDC (National Drug Code) for Retin-A .1 mg/g is 0187-5172, listed by Bausch Health US, LLC.