ACNE CONTROL CLEANSER

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 10g in 100g
Labeler: DOLGENCORP INC
NDC Code: 55910-825

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

BENZOYL PEROXIDE 10%

PURPOSE

ACNE TREATMENT

USES

FOR THE TREATMENT OF ACNE.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THE PRODUCT
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH EYES, LIPS AND MOUTH.
  • AVOID CONTACT WITH HAIR OR 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 USING THIS PRODUCT AND ASK DOCTOR IFIRRITATION OR REDNESS BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  AVOID CONTACT WITH EYES.  IF CONTACT OCCURS FLUSH THOROUGHLY WITH WATER.

DIRECTIONS
  • WET FACE. GENTLY MASSAGE ALL OVER FACE FOR 20-30 SECONDS AVOIDING EYE AREA.  RINSE THOROUGHLY AND PAT DRY.
  • SINCE EXCESSIVE DRYNES OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY AND INCREASE TO TWO TIMES A DAY IF NEEDED OR 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 USING BOTH PRODUCTS AND ASK A DOCTOR.

OTHER INFORMATION

KEEP TIGHTLY CLOSED.  AVOID STORING AT TEMPERATURES ABOVE 90 DEGREES FAHRENHEIT.

QUESTIONS OR COMMENTS

1-888-309-9030

INACTIVE INGREDIENTS

GLYCERIN, PETROLATUM, WATER, SODIUM C12-15 ALKYL BENZOATE, MINERAL OIL, SODIUM COCOYL ISETHIONATE, ZINC LACTATE, SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POTASSIUM POLYPHOSPHATE, MENTHOL, FRAGRANCE, TITANIUM DIOXIDE, CARBOMER, TRIETHANOLAMINE.

Front and back labels

ACNE CONTROL CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-825
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
GLYCERIN 
PETROLATUM 
WATER 
ALKYL (C12-15) BENZOATE  
MINERAL OIL 
SODIUM COCOYL ISETHIONATE 
ZINC LACTATE 
SODIUM C14-16 OLEFIN SULFONATE 
POTASSIUM METAPHOSPHATE 
MENTHOL 
TITANIUM DIOXIDE 
CARBOMER 934 
TROLAMINE 
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
Packaging
#Item CodePackage Description
1NDC:55910-825-05141 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D10/25/2011
Labeler - DOLGENCORP INC (068331990)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 10/2011
 
DOLGENCORP INC

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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