Retin-A .5 mg/g
Tretinoin · CREAM · Bausch Health US, LLC
Retin-A is a cream containing tretinoin at .5 mg/g, taken topical. Manufactured by Bausch Health US, LLC.
Key Facts
- Brand Name
- Retin-A
- Generic Name
- Tretinoin
- NDC Code (Product)
0187-5162- Manufacturer
- Bausch Health US, LLC
- Strength
- .5 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA017522
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 07/30/1974
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 contains Tretinoin. It is a cream taken topical. Consult your doctor for specific uses.
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 .5 mg/g?
The NDC (National Drug Code) for Retin-A .5 mg/g is 0187-5162, listed by Bausch Health US, LLC.