BENZOYL PEROXIDE- benzoyl peroxide gel 
Enrich Enterprises Xiamen Limited

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84339-001

Benzoyl Peroxide 2.5%

Acne Treatment

Use For the treatment of acne.

- For external use only.

Do not use if you

- Are sensitive to benzoyl peroxide.

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.

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

- Keep out of reach of children.

- 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.

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

84339-001-01

BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84339-001
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 980 (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPANEDIOL (UNII: 5965N8W85T)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84339-001-011 in 1 BOX05/20/2024
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00605/20/2024
Labeler - Enrich Enterprises Xiamen Limited (529499545)
Establishment
NameAddressID/FEIBusiness Operations
Enrich Enterprises Xiamen Limited529499545manufacture(84339-001)

Revised: 5/2024
Document Id: 18dddb5e-d3e1-2e8b-e063-6394a90ae28f
Set id: 18dddb5e-d3e0-2e8b-e063-6394a90ae28f
Version: 1
Effective Time: 20240520
 
Enrich Enterprises Xiamen Limited