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 3, 2014

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  • Active Ingredient

    Isopropyl Alcohol 50%

  • Purpose

    First Aid Antiseptic

  • Uses

    Help Prevent the 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 ou have deep or punture wound, animal bites or serious burns

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

    When using this product, do not get into eyes do not apply over large areas of the body

    do not use longer than a 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 contain nor is intened as substitute for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally

  • Inactive Ingredient

    Water

  • Package Label

    Alcoholimage description

  • INGREDIENTS AND APPEARANCE
    COMFORT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50827-002
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50827-002-83354 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    WEIMEI Lianyungang HOUSEHOLD ARTICLES MANUFACTURING CO.LTD546100731manufacture(50827-002)
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