5 PERCENT BENZOYL PEROXIDE CLEANSER- benzoyl peroxide gel 
Brand Evangelists for Beauty Limited

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5 Percent Benzoyl Peroxide Cleanser

Drug Facts

Active ingredients

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

• 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 a sunscreen • avoid contact with the eyes, lips and mouth • avoid contact with hair and dyed fabrics, which may be bleached by 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 ask a doctor if

irritation becomes severe.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

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

Directions

Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs follow the directions stated below.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.

Questions or Comments?

Call toll free (833) 981-2335

Package Labeling:

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5 PERCENT BENZOYL PEROXIDE CLEANSER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81136-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAUROYL HYDROXYPROPYL SULFONATE (UNII: IQ398K5X8M)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81136-023-011 in 1 CARTON08/24/2022
1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/24/2022
Labeler - Brand Evangelists for Beauty Limited (222990724)
Registrant - Orean Personal Care Ltd. (211403363)
Establishment
NameAddressID/FEIBusiness Operations
Orean Personal Care Ltd.211403363manufacture(81136-023)

Revised: 11/2023
Document Id: 09c77795-2e82-22c2-e063-6294a90afc96
Set id: e82469e2-606a-4263-9aaa-08596b59ff6b
Version: 2
Effective Time: 20231110
 
Brand Evangelists for Beauty Limited