Label: HAND SANITIZER- alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     71011-005-01, 71011-005-02, 71011-005-03, 71011-005-04, view more
    71011-005-05, 71011-005-06, 71011-005-07, 71011-005-08, 71011-005-09, 71011-005-10, 71011-005-11, 71011-005-12, 71011-005-13, 71011-005-14, 71011-005-15, 71011-005-16, 71011-005-17, 71011-005-18, 71011-005-19, 71011-005-20, 71011-005-21, 71011-005-22, 71011-005-23, 71011-005-24, 71011-005-25, 71011-005-26, 71011-005-27, 71011-005-28
  • Packager: NingBo Huize Commodity 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 August 23, 2018

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    Decreases bacteria on hands

  • Warning

    For external use only.
    Flammable: Keep away from flame or high heat
    When using this product keep out of eyes.In case of contact flush eyes with water. Avoid contact with broken skin.

    Stop use and ask a doctor if irritation or redness develop.

    Keep out of reach of children

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

  • Directions

    Rub hands thoroughly with product and allow to dry.

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C BLUE NO.1

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71011-005
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    Product Characteristics
    Coloryellow, blue, purple, brown, red, green, orangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71011-005-015 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    2NDC:71011-005-028 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    3NDC:71011-005-0310 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    4NDC:71011-005-0415 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    5NDC:71011-005-0520 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2016
    6NDC:71011-005-0630 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2016
    7NDC:71011-005-0750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    8NDC:71011-005-0860 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    9NDC:71011-005-0980 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    10NDC:71011-005-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    11NDC:71011-005-11150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    12NDC:71011-005-12200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    13NDC:71011-005-13250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    14NDC:71011-005-14300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    15NDC:71011-005-15400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    16NDC:71011-005-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    17NDC:71011-005-17600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    18NDC:71011-005-18700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    19NDC:71011-005-19800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    20NDC:71011-005-20900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    21NDC:71011-005-211000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    22NDC:71011-005-222000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    23NDC:71011-005-235 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
    24NDC:71011-005-248 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
    25NDC:71011-005-2525 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
    26NDC:71011-005-2615 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
    27NDC:71011-005-2720 mL in 1 POUCH; Type 0: Not a Combination Product10/20/2016
    28NDC:71011-005-2840 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2016
    Labeler - NingBo Huize Commodity Co.,Ltd. (544434795)
    Establishment
    NameAddressID/FEIBusiness Operations
    NingBo Huize Commodity Co.,Ltd.544434795manufacture(71011-005)
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