Label: INSTANT 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 July 15, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 60%

  • Purpose

    Antiseptic

  • Use

    Helps reduce bacteria on skin. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    do not use in or near tile eyes

  • WHEN USING

    When using this product do not use in or near tile eyes. In case of contact, rinse eyes thoroughly with water. Do not use on open skin wounds. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product.

  • Other information

    Do not store in temperature over 118°F.

  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Fragrance, May contain: Red 4 (Cl 14700), Red 33 (Cl 17200), Ext. Violet 2 (Cl160730), Blue 1 (Cl 142090), Yellow 5 (Cl 19140), Glycerine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice.

  • LABEL

    1234

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PODOPHYLLUM RESIN (UNII: 16902YVY2B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-116-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Harmon Stores Inc. (804085293)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PURLY IMP.& EXP.CO.,LTD.560436146manufacture(63940-116)
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