Label: GEL HAND SANITIZER- moisturizing gel hand sanitizer 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 May 5, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic; Hand Sanitizer

  • Uses

    To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

  • Warnings

    For external use only: Hands. Flammable, keep aware from fire or flame.

  • Do not use

    In children less than 2 months of age. On open skin or wounds.

  • 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 ir 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

    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.

  • Other information

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

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

  • Inactive Ingredients

    Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence

  • Packaging Label - Principal Display Panel

    59 ML NDC Code 75396-315-17

    FRONT

    Front 2 oz

    BACK

    Back 2 oz

    118ML NDC Code 75396-315-18

    FRONT

    Front 4 oz

    BACK

    Back 4 oz

    3785ML NDC Code 75396-315-19

    FRONT

    Front 128 oz

    BACK

    Back 128 oz

  • INGREDIENTS AND APPEARANCE
    GEL HAND SANITIZER 
    moisturizing gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75396-315
    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
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75396-315-17118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/25/2020
    2NDC:75396-315-1859 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/25/2020
    3NDC:75396-315-193785 mL in 1 JUG; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    Labeler - BuckAirways Inc. (117488255)
    Registrant - Berdor Health (117488255)
    Establishment
    NameAddressID/FEIBusiness Operations
    BuckAirways Inc.117488255manufacture(75396-315)
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