Label: INSTANT HAND SANITIZER- isopropyl alcohol spray

  • 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 April 15, 2020

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  • DRUG FACT:

  • Active ingredient:

    Isopropyl alcohol 75% v/v

  • PURPOSE:

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • WARNING:

    For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 6 years of age. On open skin wounds.

    Keep out of reach of children.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
    • supervise children under 6 years of age when using this product to avoid swallowing
  • OTHER INFORMATION:

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (100F)

  • Inactive ingredients

    Water, Vitamin E, Aloe Vera

  • SPL UNCLASSIFIED SECTION

    With Vitamin E

    Kills 99% of Germs

    Product compliant with CARB Regulations. Made in USA

    Distributed by IFS, International Fragrance Shop Baltimore, MD.

    www.intlfragshop.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74462-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74462-143-0259.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/06/2020
    Labeler - International Fragrances Inc (076876962)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Fragrances Inc076876962manufacture(74462-143)
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