Label: COMFORT- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 28, 2014

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  • Active Ingredient

    Isopropyl Alcohol 50%

    Purpose

    First Aid Antiseptic

  • Uses

    Help Prevent risk of infection in minor cuts, scrapes, burns

  • Warnings

    For external use only

    Flammable- keep away from fire or flame, heat, spark, electrical.

    Ask a doctor before use if you have deep or punture wounds, animal bites or serious burns

    Stop use and ask doctor if the condition persists or gets worse

    When using this product, do not get into eyes, do not apply over large area of the body, do not use longer than 1 week

    Keep out of reach of children

    If swallowed, get medical help or contact a posion control center immediately

  • Directions

    Clean affected area - apply a small amount of product 1 to 3 times a day

  • Other Information

    does not container nor is intended as substitue for grain or ethyl alcohol, will produce serious gastric disturbances if taken internally

  • Inactive Ingredient

    Water, Blue 1, yellow 5

  • Label

    Winter Green Alcohol

  • INGREDIENTS AND APPEARANCE
    COMFORT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50827-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50827-003-80354 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2013
    Labeler - WEIMEI Lianyungang Household Articles Manufacturing Co. LTD (546100731)
    Registrant - WEIMEI Lianyungang Household Articles Manufacturing Co. LTD (546100731)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weimei Lianyungang Household Manufacturing Co. LTD546100731manufacture(50827-003)
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