ACNE CONTROL CLEANSER - benzoyl peroxide cream 
DOLGENCORP INC

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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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 IF

IRRITATION 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

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

image of the label

ACNE CONTROL CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-825
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
ZINC LACTATE (UNII: 2GXR25858Y)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
POTASSIUM METAPHOSPHATE (UNII: 01DMT14Z63)  
MENTHOL (UNII: L7T10EIP3A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 10/2011
Document Id: df810ef7-5bd8-4bf2-b322-1b6c0531d2c3
Set id: 7a0f18cb-c79c-4f70-872c-c4958b793e59
Version: 1
Effective Time: 20111025
 
DOLGENCORP INC