Label: SHSNH6-4602- ethyl 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 June 3, 2020

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  • Drug Facts

  • Active ingredients(s)

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    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

    • on 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 and ask for a doctor if irritation 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

  • Other information

    • Store between 15-30C(59-86F)
    • Avoid freezing and excessive heat above 40C(104F)

  • INACTIVE INGREDIENT

    Inactive ingredients deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, aloe barbadensis leaf juice, glycerin, fragrance, tocopheryl acetate (vitamin E acetate), FD&C Blue #1

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SHSNH6-4602 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73870-962
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73870-962-331249 L in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - Shotwell Hydrogenics, LLC (108985732)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shotwell Hydrogenics, LLC108985732manufacture(73870-962)
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