Adapalene Gel USP, 0.3% 3 mg/g
Adapalene Gel USP, 0.3% · GEL · Encube Ethicals, Inc.
Adapalene Gel USP, 0.3% is a gel containing adapalene gel usp, 0.3% at 3 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- Adapalene Gel USP, 0.3%
- Generic Name
- Adapalene Gel USP, 0.3%
- NDC Code (Product)
21922-051- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 3 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA200298
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 08/07/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ADAPALENE Gel, 0.3% is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel,0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use. • Wash affected areas gently with a non-medicated soap. ( 2 ) • Apply a thin film of adapalene gel, to the entire face and other affected areas of the skin once daily in the evening. ( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use. ( 2 )
Contraindications
4 CONTRAINDICATIONS Adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ]. Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel,0.3%
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported (≥1%) adverse reactions were erythema,scaling, dryness, and/or burning/stinging. ( 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 reactions 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 the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene gel, 0.3% once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with Adapalene gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene ge…
Frequently Asked Questions
What is Adapalene Gel USP, 0.3% used for?
Adapalene Gel USP, 0.3% contains Adapalene Gel USP, 0.3%. It is a gel taken topical. Consult your doctor for specific uses.
Is Adapalene Gel USP, 0.3% a controlled substance?
Adapalene Gel USP, 0.3% is not classified as a controlled substance by the DEA.
What is the generic name for Adapalene Gel USP, 0.3%?
The generic name for Adapalene Gel USP, 0.3% is Adapalene Gel USP, 0.3%. There are no other listed brand versions of Adapalene Gel USP, 0.3%.
What is the NDC code for Adapalene Gel USP, 0.3% 3 mg/g?
The NDC (National Drug Code) for Adapalene Gel USP, 0.3% 3 mg/g is 21922-051, listed by Encube Ethicals, Inc..
Other Adapalene Gel USP, 0.3% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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