Tretinoin (Microsphere) .8 mg/g
tretinoin · GEL · Mayne Pharma
Tretinoin (Microsphere) is a prescription gel containing tretinoin at .8 mg/g, taken topical. Manufactured by Mayne Pharma.
Key Facts
- Brand Name
- Tretinoin (Microsphere)
- Generic Name
- tretinoin
- NDC Code (Product)
68308-777- Manufacturer
- Mayne Pharma
- Strength
- .8 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA215609
- Drug Class
- Retinoid [EPC]; Retinoids [CS]
- Marketing Start
- 10/25/2024
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 Tretinoin gel (microsphere) is a retinoid indicated for topical application in the treatment of acne vulgaris. Tretinoin gel (microsphere) is a retinoid, indicated for topical treatment of acne vulgaris. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Not for ophthalmic, oral, or intravaginal use. Tretinoin gel (microsphere) should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area in a thin layer. Areas to be treated should be cleansed thoroughly before the medication is applied. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy [see…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 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. Clinical Trials in Subjects with Acne In separate clinical trials for each concentration, acne subjects treated with tretinoin gel (microsphere), 0.1% or 0.04%, over the twelve- week period showed that cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching peaked during the initial two weeks of therapy, decreasing thereafter. Approximately half of the subjects treated with tretinoin gel (microsphere), 0.04%, had cutaneous irritation at Week 2. Of those subjects who did experience cutaneous side effects, most had signs or symptoms that were mild in severity (severity w…
Frequently Asked Questions
What is Tretinoin (Microsphere) used for?
Tretinoin (Microsphere) contains tretinoin. It is a gel taken topical. Consult your doctor for specific uses.
Is Tretinoin (Microsphere) a controlled substance?
Tretinoin (Microsphere) is not classified as a controlled substance by the DEA.
What is the generic name for Tretinoin (Microsphere)?
The generic name for Tretinoin (Microsphere) is tretinoin. There are 12 other brand versions of tretinoin.
What is the NDC code for Tretinoin (Microsphere) .8 mg/g?
The NDC (National Drug Code) for Tretinoin (Microsphere) .8 mg/g is 68308-777, listed by Mayne Pharma.