Label: KLAR AND DANVER INSTANT HAND SANTIZER- 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 December 12, 2019

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  • DRUG FACTS

    ​ACTIVE INGREDIENT

    ​Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Use

    Hand sanitizer to help decrease bacteria on the skin.

    When water, soap and towel are not available

    Recommended for repeated use

  • Warnings

    For external use only.

    Flammable. Keep away from fire and flame

    Do not apply around eyes. Do not use in ears and mouth

    When using this product

    avoid contat with eyes. In case of contact flush with water.

    Sop use andask a doctor if

    redness or irritation develop and persist formore than 72 hours.

    Keep out of reach of children

    Children must be supervised in use of this product

  • Directions

    pump as needed ito your palms and thoroughly spread on both hands

    rub into skin until dry.

  • Other Informatio

    Store at 20C (68 to 77F)

    may discolor fabrics

  • Inactive Ingredients

    Water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY GREENBRIER INTERNATIONAL INC

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320. MADE IN MEXICO

  • Product Labeling

    labels

    label2

  • INGREDIENTS AND APPEARANCE
    KLAR AND DANVER INSTANT HAND SANTIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-8010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-8010-1275 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/2015
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - 4E Global, S.A.P.I. de C.V. (812821307)
    Establishment
    NameAddressID/FEIBusiness Operations
    4E Global, S.A.P.I. de C.V.812821307manufacture(33992-8010)
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