Benzoyl Peroxide 9.5% Cleansing Cloths

BENZOYL PEROXIDE by

Drug Labeling and Warnings

BENZOYL PEROXIDE by is a Otc medication manufactured, distributed, or labeled by KMM Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BENZOYL PEROXIDE- benzoyl peroxide cloth 
KMM Pharmaceuticals, 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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Benzoyl Peroxide 9.5% Cleansing Cloths

Active ingredient

Benzoyl peroxide 9.5%

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 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.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughly 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.

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 above.

Other information

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Inactive ingredients

emulsifying wax, methylparaben, propylparaben, purified water

Questions?

1-855-899-4237

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BENZOYL PEROXIDE 
benzoyl peroxide cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52187-554
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE95 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52187-554-6060 in 1 CARTON11/03/202101/25/2022
1NDC: 52187-554-018 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/03/202101/25/2022
Labeler - KMM Pharmaceuticals, LLC (078521761)

Revised: 3/2022
Document Id: d955ac6a-ec2e-a197-e053-2a95a90a4f41
Set id: cfe90535-5b3a-4dc9-e053-2995a90ace3b
Version: 2
Effective Time: 20220303