Label: SOHO FRESH RUBBING ALCOHOL- alcohol liquid

  • 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 June 18, 2020

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  • DRUG FACTS

  • Active Ingredients

    Ethyl alcohol 70% by volume

    Purpose

  • Uses

    • to decrease germs in minor cuts and scrapes
  • Warnings

    For external use only: hands.

     Flammable, Keep away from fire of flame.

    • produce serious gastric disturbances if taken internally

    Do not use

    as a substitute for grain or ethyl alcohol-on irritated skin

    Ask a doctor before use if you have

    deep only or puncture wounds, serious burns

    When using this product

    • avoid getting into eyes or on
    • mucous membranes
    • use only in a well ventilated area

    Stop use and ask a doctor if

    • irritation  or swelling develops on the skin
    • pain persists or increase or if infection occurs

    If pregnant or breast feeding,

    ask a health professional before use

    Keep out of reach of children,

    in case of an accidental ingestion seek professional assistance, or contact a Poison Control Center immediately

  • Directions

    Apply to skin directly or with clean gauze, cotton or swab

    For rubbing apply liberally and rub with hands

  • Other information

    Keep bottle tightly closed

  • Inactive Ingredient

    purified water

  • Package Labeling

    Bottle

  • INGREDIENTS AND APPEARANCE
    SOHO FRESH RUBBING ALCOHOL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78533-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78533-001-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - ESSAAR INC. (627007441)
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