Label: MAXIM 50% ISOPROPYL RUBBING ALCOHOL- isopropyl 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 December 20, 2019

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  • Drug Facts

  • Active ingredients (by volume)

    Isopropyl alcohol (50% Conc)

  • Purpose

    First aid antiseptic

  • Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact poison control center (1-800-222-1222) immediately.

  • INDICATIONS & USAGE

    Uses • First aid to help prevent risk of infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    • flammable, keep away from fire or flame, heat, electric spark

    Ask a doctor before use if you have

    • deep punctured wounds, animals bites or serious burns

    When using this products

    • do not get into eyes

    • do not apply over large areas of the body

    • do not use longer than one week unless directed by a doctor

    Stop using this product if

    • Condition persists or gets worse

  • Directions

    • Clean affected area

    • Apply small amount of this product on the area 1-3 times daily

    • May be covered with a sterile bandage

    • If bandaged, let dry first

  • INACTIVE INGREDIENT

    Inactive ingredient Purified water

  • Other information

    • store at room temperature

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol, will produce serious gastric disturbances if taken internally.

  • SPL UNCLASSIFIED SECTION

    Use only in a well ventilated area, Fumes may be harmful.

    TAMPER EVIDENT : DO NOT USE IF THE UNDER CAP PRINTED SAFETY FOIL IS BROKEN OR MISSING.

    Made in India

    Imported By : OSTL Inc.

    5805 White Oak Ave Encino CA, 91416

    WWW.OSTLTRADE.COM

  • Packaging

    label image

  • INGREDIENTS AND APPEARANCE
    MAXIM 50% ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69950-003
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69950-003-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2015
    Labeler - OSTL, INC. (020117798)
    Establishment
    NameAddressID/FEIBusiness Operations
    WILSON MEDICINE COMPANY916000287manufacture(69950-003)
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