Label: 70% ISOPROPYL ALCOHOL WITH WINTERGREEN- isopropyl 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 February 5, 2021

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  • Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns.

    • help relieve minor muscular ache due to exertion.

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product

    • do not get into eyes. • do not apply over large areas of the body. • do not use longer than one week unless directed by doctor

    Ask a doctor before use if

    • deep puncture wounds, animal bites or serious burns.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center.

  • Directions

    • Clean affected area. • Apply small amount of the product on the area 1-3 times daily. • If bandaged, let dry first. • May be covered with a sterile bandage

  • Other Information

    • Store at room temperature. • Does not contain, nor is intended as substitute for grain or ethyl alcohol.

  • Inactive Ingredients

    Water, Methyl Salicylate, Glycerine, FD&C Blue #1, FD&C Yellow #5.

  • SPL UNCLASSIFIED SECTION

    Use for:

    + Topical Antiseptic and Sanitizer

    + Antibacterial Cleansing Agent For Minor Cuts and Abrasions

    + Preparation of Skin Prior to an Injection

    WARNING FLAMMABLE

    Keep away from heat, spark, electrical, fire or flame

    Caution: Do not point at self and others. Product will squirt when squeezed.

    Questions or Comments?

    Call (786) 477-4174

    Monday- Friday 9AM-5PM EST

    MANUFACTURED IN THE USA BY

    MAR COMPANY GROUP/AROMAR

    DORAL FL33126

    www.aromar.com

    MADE IN USA

    California Proposition 65 - This product does not contain any substance known to the state of California to cause developmental and/or reproductive harm.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73717-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73717-606-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2021
    Labeler - Mar Company Distributors, LLC (050788981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mar Company Distributors, LLC DBA AROMAR050788981manufacture(73717-606)
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