FAMILY CARE ACNE TREATMENT

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 10g in 100g
Labeler: UNITED EXCHANGE CORP.
NDC Code: 65923-006

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.

Drug Facts

Active ingredient                                                                               Purpose

Benzoyl Peroxide 10%......................................................................Acne medications

Uses

  • for the treatment and prevention of acne pimples

Warnings

  • for external use only

Do not use if you have sensitive skin or are sensitive to benzoyl peroxide

When using this product

  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product
  • with other tropical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur.  If this occurs, only one medications should be use unless directed by a doctor
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.  More frequent use or concentration may aggravate skin irritation.  Mild irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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
  • use to prevent new pimples from forming

Other information

  • keep tightly closed
  • keep away from heat

Inactive ingredients

bentonite, benzoyl peroxide, dimethicone, dried aluminum hydroxide gel, glyceryl stearate SE, isopropyl myristate, methylparaben, PEG-400, petrolatum, propylene glycol, propylparaben, tefose 63, water

Distributed by: Consumer Care Products Corp.

                      Cerritos, CA 90703 USA

Made in Korea

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FAMILY CARE ACNE TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
PROPYLENE GLYCOL 
STEARYL ALCOHOL 
SORBITAN MONOSTEARATE 
POLYSORBATE 60 
METHYLPARABEN 
BUTYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:65923-006-001 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/07/2012
Labeler - UNITED EXCHANGE CORP. (840130579)

Revised: 02/2012
 
UNITED EXCHANGE CORP.

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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