Label: MAXIM 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- 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 July 27, 2018

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  • Drug Facts

  • Active ingredients (by volume)

    Isopropyl alcohol (50%Conc)

  • Purpose

    First aid antiseptic

  • Uses

    helps 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 for deep or puncture wounds, animal bites or serious burns

    When using this products • do not get in to eyes • do not inhale • do not apply over large areas of the body • do not use longer than 1 week

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact poison control center right away. (1-800-222-1222)

  • Directions

    ​​• Clean affected area • spray a small amount of this product on the area 1 to 3 times daily • may be covered with sterile bandage • if bandaged, let dry first

  • Inactive ingredient

    Purified water, methyl salicylate, D&C Green #5, D&C Yellow #10

  • Other information

    • Keep tightly closed and at controlled 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

    FIRST AID ANTISEPTIC

    For Rubbing & Massaging

    Caution: Do not point at self or others, product will squirt when squeezed. Use only in a well-ventilated area; fumes can be harmful.

    Made in India

    Imported by : OSTL Inc.

    5805 White Oak Ave Encino CA, 91416

    WWW.OSTLTRADE.COM

  • Packaging

    355 mL

    355 mL

    295 mL

    295 mL

  • INGREDIENTS AND APPEARANCE
    MAXIM 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69950-004
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69950-004-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2015
    2NDC:69950-004-02295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2018
    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(69950-004)
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