Label: HAND SANITIZER- 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 March 31, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 62% v/v. Purpose: Antimicarobial

  • Purpose

    Antimicrobial

  • Use

    Kills 99.9% of germs on the skin.

  • Warnings

    Warnings: For extermnal use only. Flammable.
    Keep away from heat and flame.
    When using this product: avoid contact with face, eyes,
    and broken skin. In case of eye contact, flush with plenty
    of water and seek medical advice. Stop use and ask a
    doctor if rritation or redness develops.
    Keep out of reach of children. .
    If swallowed, get medical help or contact a
    Poison Control Center.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

  • Directions

    Directions: Wet hands thoroughly and rub into skin until
    dry. Children under 6 years of age should be supervised
    by an adult when using this product.

  • Inactive ingredients

    Inactive Ingredients: Water, Glycerine,
    Carbomer, VE, Flavor

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73946-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73946-001-0124 in 1 CARTON03/30/2020
    12 in 1 CONTAINER
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73946-001-0296 in 1 CARTON03/30/2020
    224 in 1 BOX
    22 in 1 CONTAINER
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:73946-001-0396 in 1 CARTON03/30/2020
    324 in 1 BOX
    330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:73946-001-0424 in 1 CARTON03/30/2020
    42 in 1 CONTAINER
    450 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:73946-001-0524 in 1 CARTON03/30/2020
    5237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:73946-001-0624 in 1 CARTON03/30/2020
    6500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:73946-001-0772 in 1 CARTON03/30/2020
    7100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:73946-001-0812 in 1 CARTON03/30/2020
    81000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Yiwu Jiefei Daily Chemicals Co.,Ltd. (542996874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Jiefei Daily Chemicals Co.,Ltd.542996874manufacture(73946-001)