Label: MEDICATED ACNE SHOWER- salicylic acid gel

  • 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 July 11, 2014

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE IF YOU HAVE  KNOWN ALLERGY TO SALICYLIC ACID OR ASPERIN.

  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF TH SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

  • STOP USE

    STOP USE ND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

    • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
    • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • USE MORNING AND NIGHT.
    • WET AREA TO BE CLEANSED.
    • APPLY ACNE TREATMENT ND GENTLY MASSAGE AREA FOR 1-2 MINUTES..
    • RINSE THOROUGHLY AND PAT DRY.
    • RINSE THOROUGHLY WITH WATER..
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, SODIUM C14-16 OLEFIN SULFONATE, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFOACETATE, PEG-150 DISTEARATE, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, AMINOMETHYL PROPANOL, SODIUM CHLORIDE, GLYCERIN, ALLANTOIN

  • QUESTIONS

    QUESTIONS OR COMMENTS? 1-877-445-4624

  • PRINCIPAL DISPLAY PANEL

    Acne Body Wash 2-SA Gel_label

  • INGREDIENTS AND APPEARANCE
    MEDICATED ACNE SHOWER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58876-108-30295 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/13/2013
    Labeler - DR LIN SKINCARE (622329980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.069926483manufacture(58876-108) , pack(58876-108)
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