ISOMERS CLEAR SKIN ACNE TREATMENT LOTION - 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.

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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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Warnings:

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Inactive Ingredients:

Purified Water, Cetearyl Alcohol, Ceteth 20 Phosphate, Dicetyl Phosphate, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, C 10- 30 Cholesterol Lanosterol Esters, Optunia Ficus Indica Stem extract, Boerhavia Diffusa root extract, Thermus Thermophilus Ferment, Pentylene Glycol, Phenoxyethanol, Tropolone, Decylene Glycol, C 20-40 Pareth-10, Zinc PCA, Sodium Hydroxide.

CSATL120.jpgimage of product label


ISOMERS CLEAR SKIN ACNE TREATMENT LOTION 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-605
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64990-605-06120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/26/2009
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers laboratories Inc (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers laboratories Inc253306799manufacture

Revised: 2/2010
Document Id: f2a273b5-ab49-4c45-8f5b-ef9a3cecc1ed
Set id: 83fffc5c-0e61-4083-8fac-5612f7a6911f
Version: 1
Effective Time: 20100209
 
Isomers Laboratories Inc