Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 77050-016-01, 77050-016-02, 77050-016-03, 77050-016-04, view more
    77050-016-05, 77050-016-06, 77050-016-07, 77050-016-08, 77050-016-09, 77050-016-10, 77050-016-11
  • Packager: Global Exports U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • Active Ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer 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

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using products.
  • Other information

    • Store below 110°F(43C°)
    • Avoid freezing and excessive heat above 104°F(40°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

  • Package Label - Principal Display Panel

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77050-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Lemon Oil (UNII: I9GRO824LL)  
    Glycerin (UNII: PDC6A3C0OX)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Carbomer Interpolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77050-016-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    2NDC:77050-016-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    3NDC:77050-016-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    4NDC:77050-016-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
    5NDC:77050-016-05946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
    6NDC:77050-016-061893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    7NDC:77050-016-071893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
    8NDC:77050-016-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    9NDC:77050-016-093785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
    10NDC:77050-016-1018927 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2020
    11NDC:77050-016-1118927 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/04/2020
    Labeler - Global Exports U.S.A., Inc. (607803517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Exports U.S.A., Inc.607803517PACK(77050-016) , LABEL(77050-016)
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