Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 29, 2020

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  • Active Ingredient

    Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    Uses

    • Hand sanitizer to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    Warnings

    For external use only Flammable

    • Keep away from fire or flame
  • When using

    When using this product:

    • Do not use in or near eyes

    If contact occurs, rinse eyes thoroughly with water.

  • Stop use

    Stop use and ask a doctor

    • If irritation and redness persist for more than 72 hours.
  • Keep out of reach

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control centerimmediately

  • Directions

    Directions

    • Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Children under six years of age should be supervised when using this product.
  • Other information

    Other Information

    • Store at 1 oC - 30 oC (34 oF - 86 oF)
  • Inactive ingredients

    Inactive Ingredients

    Carbomer, Glycerin, Triethanolamine, Water

  • PDP

    LabelEthyl Alcohol

    70%

    all clear

    Hand

    Sanitizer

    Fragrance Free

    Kills 99.99 of germs

    16.9 fl oz 500ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77070-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    Product Characteristics
    Colorwhite (Clear colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77070-700-80500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/07/2020
    Labeler - GoodFibers (105870470)
    Registrant - GoodFibers (105870470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biotechnologia Educacion y Genetica, S.A. de C.V.951580322manufacture(77070-700)
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