ACNE GEL- benzoyl peroxide gel
SKIN PLUS, LIMITED LIABILITY COMPANY

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.

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Acne Gel 5%

Inactive Ingredients

Active Ingredients

Other Information

Purpose

Warnings

Warning

Purpose

Warning

Acne Gel

ACNE GEL
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82172-230
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82172-230-30	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	02/16/2023

Labeler - SKIN PLUS, LIMITED LIABILITY COMPANY (060500187)

Registrant - SKIN PLUS, LIMITED LIABILITY COMPANY (060500187)

Name	Address	ID/FEI	Business Operations
Establishment
Freelance Formulations LLC		098871137	manufacture(82172-230)