CP DR. BABOR PURITY CELLULAR STOP BLEMISH FLUID- salicylic acid liquid 
Babor Cosmetics America, Corp.

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

Salicylic acid 2.0%

Purpose

Acne treatment

Keep out of reach of children.

Use

For the treatment of acne

  • Helps clear up acne blemishes and allows skin to heal.
  • Penetrates pores to reduce the number of acne blemishes.
  • Helps prevent new acne blemishes from forming.

Warnings

For external use only

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Directions

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

Other Information

You may report a serious adverse reaction to this product to: 

BABOR Cosmetics America Corp.

931 Village Boulevard

Suite 905-359

West Palm Beach, FL 33409-1939

Inactive Ingredients

Water, SD alcohol, butylene glycol, alpha-glucan oligosaccharide, glycerin, caprylyl/capryl glucoside, panthenol, xanthan gum, sodium hydroxide, enantia chlorantha bark extract, allantoin, silver, eugenol, phragmites kharka extract, poria cocos extract, sodium benzoate, eugenia caryophyllus (clove) flower oil, pantolactone, citric acid, oleanolic acid, methyl eugenol.

i

o

CP DR. BABOR PURITY CELLULAR STOP BLEMISH FLUID 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44924-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 30 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
ALLANTOIN (UNII: 344S277G0Z)  
SILVER (UNII: 3M4G523W1G)  
EUGENOL (UNII: 3T8H1794QW)  
PHRAGMITES AUSTRALIS WHOLE (UNII: 8E5JPP4H6F)  
FU LING (UNII: XH37TWY5O4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CLOVE OIL (UNII: 578389D6D0)  
PANTOLACTONE, (+/-)- (UNII: IID733HD2M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
METHYL EUGENOL (UNII: 29T9VA6R7M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44924-133-021 in 1 BOX08/15/201302/17/2017
1NDC:44924-133-0130 mg in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/201302/17/2017
Labeler - Babor Cosmetics America, Corp. (139251763)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Babor GmbH & Co. KG315989384manufacture(44924-133)

Revised: 2/2017
 
Babor Cosmetics America, Corp.