Your browser does not support JavaScript! BLEMISH CORRECTING SERUM (BENZOYL PEROXIDE) GEL [CEN BEAUTY LLC]
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BLEMISH CORRECTING SERUM (benzoyl peroxide) gel
[CEN BEAUTY LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

PURPOSE

ACNE TREATMENT

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE

WHEN USING THIS PRODUCT

  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH. AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THE 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.
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

  • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
  • AVOID THE DELICATE EYE AREA.
  • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO 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.
  • CONSULT A PHYSICIAN BEFORE USE.

Other Information

Store at 15-30°C (59-86°F)

INGREDIENTS

aqua (water), diglycerin, propanediol, butylene glycol, salicylic acid, allantoin, bisabolol, glycerin, angelica sinensis extract, avena sativa (oat) kernel extract, lecithin, ethylhexylglycerin, carbomer, acrylates/C10-30 alkyl acrylate , crosspolymer, aminomethyl propanol, phenoxyethanol, potassium sorbate

BB_Blemish Correcting Serum-BPO CX223

BB_Blemish Correcting Serum-BPO_1oz_Tubes_ARTWORK_FR

BLEMISH CORRECTING SERUM 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54272-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIGLYCERIN 
PROPANEDIOL 
BUTYLENE GLYCOL 
SALICYLIC ACID 
ALLANTOIN 
.ALPHA.-BISABOLOL, (+/-)- 
GLYCERIN 
ANGELICA SINENSIS WHOLE 
GLYCERIN 
ANGELICA SINENSIS WHOLE 
AVENA SATIVA TOP 
LECITHIN, SOYBEAN 
ETHYLHEXYLGLYCERIN 
CARBOMER 934 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
AMINOMETHYLPROPANOL 
PHENOXYETHANOL 
POTASSIUM SORBATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54272-102-1130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/21/2013
Labeler - CEN BEAUTY LLC (078664118)
Registrant - CEN BEAUTY LLC (078664118)

Revised: 2/2013
 
CEN BEAUTY LLC

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