BENZEFOAM- benzoyl peroxide aerosol 
Bausch Health US, LLC

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Drug Facts

Active ingredient

Benzoyl Peroxide (5.3%)

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 are 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.
  • do not puncture or incinerate container. Contents under pressure.
  • do not expose to temperatures above 120°F (49°C).

Stop use and ask a doctor if

■ irritation becomes severe

Keep Out of Reach of Children

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

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • can be used as either a leave-on or short contact application

Other Information

■ store at room temperature 15°-25°C (59°-77°F). Protect from freezing. Store upright.

Inactive Ingredients

BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, hydrofluorocarbon 134a, methylparaben, propylene glycol, propylparaben, purified water,

sodium citrate, steareth-10

Questions/comments?

Call: 1-800-321-4576

Package/Label Principal Display Panel - Carton

NDC: 0187-0194-10

BenzEFoam
EmollientFoam
benzoyl peroxide 5.3%

Acne Treatment
Emollient Foam

For Topical Use Only
Do Not Use in Eyes

Will not dispense entire contents.
Container is overfilled to guarantee
dispensing a minimum of 100 grams.

Back Applicator Included

Ortho Dermatologics

Net Wt 3.5 OZ (100 g)

carton.jpg
BENZEFOAM 
benzoyl peroxide aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-0194
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
NORFLURANE (UNII: DH9E53K1Y8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STEARETH-10 (UNII: FD0913P475)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-0194-101 in 1 CARTON02/06/2020
1100 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00602/06/202012/31/2021
Labeler - Bausch Health US, LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals001207208manufacture(0187-0194)

Revised: 8/2024
 
Bausch Health US, LLC