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Acne Face and Body

Dosage form: shampoo, suspension
Ingredients: BENZOYL PEROXIDE 25mg in 1mL
Labeler: Face Reality Skin Care, LLC
NDC Code: 70707-101

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.

Acne Face and Body Scrub

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

For the treatment of Acne

Uses

Adults and children 12 years and over:

  • For the treatment of acne.
  • For acne-prone or oily skin.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.

Do not use

this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.

Keep out of reach of children.

Directions

Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.

Other Information

May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients

Purified Water, Ammonium Lauryl Sulfate, Glycerin, Cellulose Acetate, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, Fragrance.

Package Labeling:

ACNE FACE AND BODY 
benzoyl peroxide shampoo, suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70707-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
GLYCERIN 
CELLULOSE ACETATE 
DISODIUM COCOAMPHODIACETATE 
PROPYLENE GLYCOL 
CARBOXYPOLYMETHYLENE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:70707-101-06180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/30/2016
Labeler - Face Reality Skin Care, LLC (602958071)

Revised: 01/2017
 
Face Reality Skin Care, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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