Label: NOT HAVE- 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 April 22, 2020

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  • Active ingredient

    ALCOHOL 73.0%

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to help reduce bacteria on skin.

  • WARNINGS

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

  • DO NOT USE

  • When using this product

    do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.If swallowed,get medical help or contact a Poison Control Center right away.

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

    Children under 6 years of age should be supervised when using this product.

  • Other Information

    Store below 106°F.(4I°C)

    May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENTS

    WATER.GLYCERIN.CARBOMER.TRIETHANOLAMINE.

  • Package Label - Principal Display Panel

    5 ml label 50 ml label 60 ml label 100 ml label 200 ml label 300 ml label 500 ml label 1 L label

  • INGREDIENTS AND APPEARANCE
    NOT HAVE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75439-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75439-001-015 mL in 1 BAG; Type 0: Not a Combination Product05/05/2020
    2NDC:75439-001-0250 mL in 1 AMPULE; Type 0: Not a Combination Product05/05/2020
    3NDC:75439-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    4NDC:75439-001-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    5NDC:75439-001-05200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    6NDC:75439-001-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    7NDC:75439-001-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    8NDC:75439-001-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/05/2020
    Labeler - Guangzhou Yucaitang Cosmetics Co., Ltd. (526897391)
    Registrant - Guangzhou Yucaitang Cosmetics Co., Ltd. (526897391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yucaitang Cosmetics Co., Ltd.526897391manufacture(75439-001)
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