Your browser does not support JavaScript! BLEMISH CORRECTING SERUM SENSITIVE (SALICYLIC ACID) GEL [CEN BEAUTY LLC]
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BLEMISH CORRECTING SERUM SENSITIVE (salicylic acid) 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

SALICYLIC ACID 2%

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

  • 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 20-25 DEGREES CELCIUS (68-78 DEGREES FAHRENHEIT)

INGREDIENTS

aqua (water), ethoxydiglycol, butylene glycol, glycereth-7 trimethyl ether, aminomethylpropanol, potassium azeloyl, diglycinate, syringa vulgaris (lilac) leaf cell culture extract, dipotassium glycyrrhizate, urea, angelica sinensis extract, avena sativa (oat) extract, avena sativa (oat) kernel extract, hamamelis virginiana (witch hazel) , bark/leaf/twig extract, papain, betaine, calcium pantothenate, proline, Alanine, serine, magnesium lactate, potassium lactate, lecithin, glycerin, maltodextrin , ethylhexylglycerin, sodium citrate, xanthan gum, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, magnesium chloride, benzyl alcohol , sorbic acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

BB_Blemish Correcting Serum-Sensitive-SA CX620S

BB_Blemish Correcting Serum-Sensitive-SA_1oz_Tubes_ARTWORK_FR

BLEMISH CORRECTING SERUM  SENSITIVE
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54272-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLENE GLYCOL MONOETHYL ETHER 
BUTYLENE GLYCOL 
GLYCERETH-7 TRIMETHYL ETHER 
AMINOMETHYLPROPANOL 
POTASSIUM AZELOYL DIGLYCINATE 
SYRINGA VULGARIS WHOLE 
GLYCYRRHIZINATE DIPOTASSIUM 
UREA 
ANGELICA SINENSIS WHOLE 
AVENA SATIVA TOP 
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
PAPAIN 
BETAINE 
CALCIUM PANTOTHENATE 
PROLINE 
ALANINE 
SERINE 
MAGNESIUM LACTATE 
POTASSIUM LACTATE 
LECITHIN, SOYBEAN 
GLYCERIN 
MALTODEXTRIN 
ETHYLHEXYLGLYCERIN 
SODIUM CITRATE 
XANTHAN GUM 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
MAGNESIUM CHLORIDE 
BENZYL ALCOHOL 
SORBIC ACID 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54272-103-1130 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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