Label: ISOMERS CLEAR SKIN ACNE TREATMENT LOTION- salicylic acid lotion

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated February 9, 2010

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  • ACTIVE INGREDIENT

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    Active ingredient:

    Salicylic Acid            2%

  • PURPOSE

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    Purpose:

    Acne Treatment

  • ASK DOCTOR

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    STOP USE AND ASK DOCTOR

    If irritation becomes Severe

  • KEEP OUT OF REACH OF CHILDREN

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    Keep out of reach of children

  • WARNINGS

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    Warnings:

    • For external use only
    • Keep away from eyes
    • Using other topical acne medications 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 INGREDIENT

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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.

  • PRINCIPAL DISPLAY PANEL

    CSATL120.jpgimage of product label


  • INGREDIENTS AND APPEARANCE
    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
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