Label: AFASSCO HAND SANITIZER- alcohol liquid

  • NDC Code(s): 71734-206-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
  • 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 October 18, 2018

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic wash hands without water

  • Uses

    for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available.

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Flammable: keep away from fire or flame

    Keep out of the reach of children.

    If contact with eyes occurs rinse thoroughly with water.

    If irritation or redness develops consult a physician.

    When using this product

    • keep out of eyes. 

    consult a physician

    if irritation or redness develops

    Keep out of reach of children.

    keep out of the reach of children

  • Directions

    • for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available.
  • Inactive Ingredients

    purified water, glycerine, carbomer, aloe essence

  • Product Labeling

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    AFASSCO HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-206-012 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/18/2018
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-206)
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