Label: ACNE GEL- benzoyl peroxide gel
- NDC Code(s): 82172-230-30
- Packager: SKIN PLUS, LIMITED LIABILITY COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 15, 2023
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- Inactive Ingredients
- Active Ingredients
- Other Information
- Purpose
- Warnings
- Warning
- Purpose
- Purpose
- Warning
- Acne Gel
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INGREDIENTS AND APPEARANCE
ACNE GEL
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82172-230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.3 g in 100 g BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 12 g in 100 g CARBOMER 940 (UNII: 4Q93RCW27E) 1 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82172-230-30 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/16/2023 Labeler - SKIN PLUS, LIMITED LIABILITY COMPANY (060500187) Registrant - SKIN PLUS, LIMITED LIABILITY COMPANY (060500187) Establishment Name Address ID/FEI Business Operations Freelance Formulations LLC 098871137 manufacture(82172-230)
