HUMANE ACNE WASH- benzoly peroxide cream 
Humane Consumer, 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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humane acne wash

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

use

for the treatment of acne.

Warnings

For external use only.

Do not use

  • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.
  • Using other topical acne drugs at the same time or right after use of the product may increase dryness, redness or irritation of the skin.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if neede. If bothersome dryness or peeling occurs, reduce application to once per day.
  • Do not use for prolonged periods without contacting a doctor.

When using this product

  • Avoid contact with eyes. of contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid Product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this Product.

Stop use and ask a doctor

if excessive irritation occurs.

Keep out of reach of children.

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

Directions

Cleanse Skin thoroughly before applying medication. Apply even layer over affected area. Rinse well. DO not use on broken skin or large parts of the body. For best results, apply one to three times per day.

Inactive ingredients

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide.

Product Label

Box

HUMANE ACNE WASH 
benzoly peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69919-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69919-021-011 in 1 CARTON02/08/2017
1237 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/28/2015
Labeler - Humane Consumer, LLC (079845933)

Revised: 2/2017
Document Id: 4807fb60-8d17-6e61-e054-00144ff8d46c
Set id: 7674be57-7a8c-449e-9f48-2b772c58c88b
Version: 3
Effective Time: 20170208
 
Humane Consumer, LLC