ACNE CONTROL CLEANSER: Package Insert and Label Information

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.

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

  • 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

image of the label
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ACNE CONTROL CLEANSER
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-825
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:55910-825-05 141 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 10/25/2011
Labeler — DOLGENCORP INC (068331990)
Registrant — APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 10/2011 DOLGENCORP INC

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