Label: HAND SANITISER- isopropyl alcohol spray

  • 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 16, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 67% w/w

    Drug Facts

  • Purpose

    Antiseptic

  • Use(s)

    Hand sanitiser spray to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age

    • on open skin wounds

  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use

    if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Dosage

    wet hands thoroughly with product and allow to dry without wiping

  • Other Information

    • Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Mentha piperita leaf water, Glycerin, Mentha piperita oil, Eucalyptus globulus leaf oil, Phenoxyethanol, Ethylhexylglycerin, Limonene, CI 42090, CI 16035.

  • PRINCIPAL DISPLAY PANEL

    50ml. 76916-167-15

    50ml Label

    Directions

  • PRINCIPAL DISPLAY PANEL

    200ml. 76916-167-12

    200ml Label.Directions.

  • INGREDIENTS AND APPEARANCE
    HAND SANITISER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76916-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.67 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000028 mL  in 50 mL
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.0008 mL  in 50 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.0000108 mL  in 50 mL
    WATER (UNII: 059QF0KO0R) 0.001135 mL  in 50 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.000025 mL  in 50 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 50 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.0008 mL  in 50 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0000012 mL  in 50 mL
    MENTHA PIPERITA LEAF (UNII: A389O33LX6) 0.2272 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76916-167-1550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/10/2020
    2NDC:76916-167-12200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/10/2020
    Labeler - WESTBARNCO LTD (222350573)
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