CLEAR SKIN ACNE TREATMENT  - salicylic acid lotion 
Isomers Laboratories 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:

SALICYLIC ACID 2% W/W

PURPOSE:

ACNE TREATMENT

STOP USE AND ASK DOCTOR IF IRRITATION BECOME SEVERE.

KEEP OUT OF REACH OF CHILDREN

  • FOR EXTERNAL USE ONLY
  • KEEP AWAY FROM EYES
  • USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN,IF THIS OCCURS ONLY ONE MEDICATION SHOULD BE USED.
  • IN CASE OF ACCIDENTAL INGESTION SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

INACTIVE INGREDIENTS:

PURIFIED WATER, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PROPYLENE GLYCOL, CETETH-20 PHOSPHATE, DICETYL PHOSPHATE, PHENOXYETHANOL, C20-40 PARETH-10, TROPOLONE, SODIUM HYDROXIDE.

IMAGE OF PRODUCT LABEL

MM10
CSATL1120.jpg

Clean the Skin thoroughly before applying the product.Cover the entire face affected are with a thin layer 1 to 3 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.

1 to 3 times per day.If bothersome dryness or peeling occurs,reduce application to once a day or every other day.
CLEAR SKIN ACNE TREATMENT  
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-610
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid0.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cetostearyl Alcohol 
Cetyl Alcohol 
MEDIUM-CHAIN TRIGLYCERIDES  
Propylene Glycol 
Phenoxyethanol 
Sodium Hydroxide 
Dihexadecyl Phosphate 
C20-40 Pareth-10 
Packaging
#Item CodePackage Description
1NDC:64990-610-10120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/27/2012
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers Laboratories Inc (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers Laboratories Inc.253306799manufacture

Revised: 04/2012
 
Isomers Laboratories Inc