ISOMERS CLEAR SKIN ACNE TREATMENT GEL - salicylic acid gel 
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.

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DRUG FACTS

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ACTIVE INGREDIENT

SALICYLIC ACID         2%

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PURPOSE

ACNE TREATMENT

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STOP USE AND ASK DOCTOR

IF IRRITATION BECOMES SEVERE

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KEEP OUT OF REACH OF CHILDREN

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WARNING:

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INACTIVE INGREDIENTS:

Purified water, Propylene Glycol, Optunia Ficus Indica Stem Extract, Boerhavia Diffusa root Extract, Thermus Thermophilus Ferment, Glycerin, Pentylene Glycol, Zinc PCA,, Hydroxyethyl Cellulose, Phenoxyethanol, Decylene Glycol, Sodium Stearoyl Lactylate, Sodium Hydroxide.

CSATG240.jpgimage of product label

ISOMERS CLEAR SKIN ACNE TREATMENT GEL 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64990-601-03240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/28/2009
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers Laboratories Inc (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers Laboratories Inc253306799manufacture

Revised: 2/2010
Document Id: 6cba7d97-428d-4655-a3cd-768a294d7ba5
Set id: 7ade773b-ba2f-4f93-9808-d0a06c61faf2
Version: 5
Effective Time: 20100217
 
Isomers Laboratories Inc