Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 51414-912-01, 51414-912-02, 51414-912-03, 51414-912-04, view more
    51414-912-05, 51414-912-06, 51414-912-07, 51414-912-08, 51414-912-09, 51414-912-10, 51414-912-11, 51414-912-12, 51414-912-13, 51414-912-14, 51414-912-15, 51414-912-16, 51414-912-17, 51414-912-18, 51414-912-19
  • Packager: Yuyao Jessie 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 March 18, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    for hand sanitizing

  • Warnings

    For external use only.
    Flammable, Keep away from heat or flame,
    When using this product keep out of eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

    Stop use and ask a doctor if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. except under adult supervision.

    If swallowed, get medical help or call a poison control center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

    For children under 6 age use only under adult supervision.

    Not recommended for infants.

  • Inactive ingredients

    Carborner,Fragrance,Glycerin,Propylene Glycol,TocopherylAcetate,Triethanolamine,Water.

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-912
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-912-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    2NDC:51414-912-0210 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    3NDC:51414-912-0315 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    4NDC:51414-912-0420 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    5NDC:51414-912-05480 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    6NDC:51414-912-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    7NDC:51414-912-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    8NDC:51414-912-0850 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    9NDC:51414-912-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    10NDC:51414-912-10120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    11NDC:51414-912-1190 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    12NDC:51414-912-128 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    13NDC:51414-912-130.9 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    14NDC:51414-912-145 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    15NDC:51414-912-1525 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    16NDC:51414-912-16240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    17NDC:51414-912-1735 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    18NDC:51414-912-1875 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    19NDC:51414-912-1918 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/10/2020
    Labeler - Yuyao Jessie Commodity Co., Ltd. (529892305)
    Registrant - Yuyao Jessie Commodity Co., Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co., Ltd.529892305manufacture(51414-912)
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