Label: HAND SANITIZER- alcohol gel

  • 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 October 25, 2021

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  • Active Ingredient(s)

    Ethyl Alcohol 67%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor If irritation redness develop.

    If condition persists for more than 72 hours.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands
    • Children under 6 years of age should be supervised when using this product
    • Rub hands together briskly until dry
  • Other information

    • Protect the product in this container

    from excessive heat and direct sun.

    • Store below 104°F (40°C)
    • May discolor certain fabrics.
  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Juice, Radish Root Ferment Filtrate, Fragrance (parfum), Glycereth-26, Lime (Citrus Aurantifolia) Seed Oil, Lemon (Citrus Limon) Peel Oil, FD&C Red No. 40, FD&C Yellow No. 5, Limonene, Citral, Citronellol, Linalool

  • Package Label - Principal Display Panel

    Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-30 75778-006-01_3-bottle combination package_45 mL

    Bottle 1 of 3, Water Melon scent 45 mL NDC: 75778-006-30 75778-006-01_Water Melon scent bottle 45 mL

    Bottle 2 of 3, Citrus scent 45 mL NDC: 75778-006-30 75778-006-01_Citrus scent bottle 45 mL

    Bottle 3 of 3, Vanilla Cinnamon scent 45 mL NDC: 75778-006-30 75778-006-01_Vanilla Cinnamon scent bottle 45 mL

    Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-31 75778-006-02_3-bottle combination package_45 mL

    Bottle 1 of 3, Lavender scent 45 mL NDC: 75778-006-31 75778-006-02_Lavender scent bottle 45 mL

    Bottle 2 of 3, Mint scent 45 mL NDC: 75778-006-31 75778-006-02_Mint scent bottle 45 mL

    Bottle 3 of 3, Aloe Vera scent 45 mL NDC: 75778-006-31 75778-006-31_Aloe Vera scent bottle 45 mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS AURANTIFOLIA SEED OIL (UNII: EW089HAI77)  
    LEMON OIL, TERPENELESS (UNII: X69W83NI7V)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75778-006-301 in 1 PACKAGE, COMBINATION10/25/2021
    13 in 1 PACKAGE
    145 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:75778-006-311 in 1 PACKAGE, COMBINATION10/25/2021
    23 in 1 PACKAGE
    245 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/14/2021
    Labeler - Audy Global Enterprises Inc. (079171473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhongrong Technology Corporation Ltd.529575698manufacture(75778-006)
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