Benzoyl Peroxide by Enrich Enterprises Xiamen Limited BENZOYL PEROXIDE gel

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Enrich Enterprises Xiamen Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 2.5%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

Use For the treatment of acne.

WARNINGS

- For external use only.

DO NOT USE

Do not use if you

- Are sensitive to benzoyl peroxide.

WHEN USING

When using this product

- Avoid unnecessary sun exposure and use an SPF.

-Avoid contact with the eyes, lips, mouth and hair.

- Skin irritation, redness, burning, itching or peeling may occur.

- Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur.

- Keep out of reach of children.

-If swallowed get medical help or call poison control center immediately.

STOP USE

- If swallowed get medical help or call poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

- Keep out of reach of children.

DOSAGE & ADMINISTRATION

- Clean the skin gently before applying this product.

- Cover the affected area with a fingertip unit of product once or twice daily.

- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

Other Ingredients: Water, Propanediol, Glycerin, Carbomer, Sodium Phytate, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84339-001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPANEDIOL (UNII: 5965N8W85T)
PHYTATE SODIUM (UNII: 88496G1ERL)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84339-001-01	1 in 1 BOX	05/20/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/20/2024

Labeler - Enrich Enterprises Xiamen Limited (529499545)

Establishment
Name	Address	ID/FEI	Business Operations
Enrich Enterprises Xiamen Limited		529499545	manufacture(84339-001)