Label: WASH FREE 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 April 17, 2020

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  • Active Ingredient

    Ethyl Alcohol(75%V/V)

  • Purpose

    Antimicrobial

  • USAGE

    Helps decrease bacteria on skin.

    Recommend for repeated use.

  • 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,immediately rinse eyes with water.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

  • KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS

    Apply as needed into yourpalms and thoroughly spread on both handsChildren under 6 years of age should besupervised when using this product.

  • OTHER INFORMATION

    Store below 106°F.(41℃)

    May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENTS

    Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Extract,
    Poterium Sanguisorba Root Extract, Atractyloides Chinensis Extract, Parfum

  • Package Label - Principal Display Panel

    30 ml label 50 ml label 100 ml label 300 ml label 500 ml label

  • INGREDIENTS AND APPEARANCE
    WASH FREE INSTANT HAND SANITIZER 
    wash free instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75137-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SANGUISORBA MINOR ROOT (UNII: 11YGU8I0TT)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75137-003-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    2NDC:75137-003-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    3NDC:75137-003-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    4NDC:75137-003-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    5NDC:75137-003-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Guangzhou JiuTai Bio-technology Co., Ltd. (554527493)
    Registrant - Guangzhou JiuTai Bio-technology Co., Ltd. (554527493)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou JiuTai Bio-technology Co., Ltd.554527493manufacture(75137-003)
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