BENZOYL PEROXIDE DEEP CLEANSING FOAMING WASH- benzoyl peroxide cream 
AcneFree, LLC

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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10 percent Benzoyl Peroxide

Purpose

Acne Treatment

USE

for the treatment of acne

Warnings

For external use only

Do not use if you

have very sensitive skin are sensitive to benzoyl peroxide

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

• avoid unnecessary sun exposure and use sunscreen

• avoid contact with the eyes, lips, and mouth

• avoid contact with hair and dyed fabrics, which may be bleached by using this product

• skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and sk a doctor if skin irritation becomes severe. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children

Keep out of Reach of children

Directions

use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• use wash on entire affected area one to two times daily

• because excessive drying of the skin may occur, start with washing one daily, then gradually increase to two times daily as needed, or directed by a doctor

• if bothersome dryness or peeling occurs, reduce cleansing to once a day or every other day

• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

• may be used on chest or back

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Sodium C14-16 Oleon Sulfonate, Xanthan Gum, Citric Acid, Potassium Hydroxide, Sodium Hyaluronate, Niacinamide, Sodium Sulfate, Avena Sativa (Oat) Kernel Extract, Sodium Lauroyl Lactylate, Glycolic Acid, Phenoxyethanol, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Ceramide EOP

Questions or comments

1-888-768-2913

Package Label

BPO Deep Cleansing Foaming Wash

BENZOYL PEROXIDE DEEP CLEANSING FOAMING WASH 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorwhite (cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-112-011 g in 1 TUBE; Type 0: Not a Combination Product06/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00606/21/2023
Labeler - AcneFree, LLC (122237140)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging System, INC dba Paklab177711082manufacture(80861-112)

Revised: 6/2023
Document Id: fe2d0e24-8c69-b2ea-e053-6294a90ad72c
Set id: fe2d0e24-8c68-b2ea-e053-6294a90ad72c
Version: 1
Effective Time: 20230620
 
AcneFree, LLC