benzoyl peroxide 5 g/100g
BENZOYL PEROXIDE · LIQUID · Bryant Ranch Prepack
benzoyl peroxide is a liquid containing benzoyl peroxide at 5 g/100g, taken topical. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- benzoyl peroxide
- Generic Name
- BENZOYL PEROXIDE
- NDC Code (Product)
72162-2338- Manufacturer
- Bryant Ranch Prepack
- Strength
- 5 g/100g
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- M006
- Marketing Start
- 01/24/2013
Recall History
MCKESSON CORPORATION
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Medicis Pharmaceutical Corp
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Private Label Skin Care Inc.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Fruit Of The Earth, Inc.
Chemical contamination: presence of benzene
Valeant Pharmaceuticals
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Milbar Laboratories, Inc.
GMP Deviations
Valeant Pharmaceuticals
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Private Label Skin Care Inc.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Allergan PLC
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
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 Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use only; adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use. (2) Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. (2)
Contraindications
4 CONTRAINDICATIONS None None. (4)
Drug Interactions
7 DRUG INTERACTIONS Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel 0.1% / 2.5%.
Adverse Reactions
6 ADVERSE REACTIONS Most commonly reported adverse events (≥1%) in patients treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. (6) 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. During clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel 0.1% / 2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1 : Table 1. Drug Related Adverse Events Reported in C…
Frequently Asked Questions
What is benzoyl peroxide used for?
benzoyl peroxide contains BENZOYL PEROXIDE. It is a liquid taken topical. Consult your doctor for specific uses.
Is benzoyl peroxide a controlled substance?
benzoyl peroxide is not classified as a controlled substance by the DEA.
What is the generic name for benzoyl peroxide?
The generic name for benzoyl peroxide is BENZOYL PEROXIDE. There are 11 other brand versions of BENZOYL PEROXIDE.
What is the NDC code for benzoyl peroxide 5 g/100g?
The NDC (National Drug Code) for benzoyl peroxide 5 g/100g is 72162-2338, listed by Bryant Ranch Prepack.
Other Benzoyl Brands
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- OXY Advanced Care Soothing Cream Acne Cleanser100 mg/g10742-1206
- OXY Rapid Spot Treatment Maximum Action100 mg/g10742-1301
- Proactivplus Skin Smoothing Exfoliator2.5 mg/100mL11410-011
- Meijer Acne Treatment Acne medication100 mg/g41250-347
- La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine49967-282
- Twyneo30 mg/g51862-771
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)