Label: DR.DAVEY- ethyl alcohol liquid

  • 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 April 24, 2020

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  • Active lngredient  

    Ethyl Alcohol

  • Purpose 

    Antiseptic

  • Uses

    • hand sanitizer to help decrease bacteria on the skin, when water, soap & towel are not available.
    • recommended for repeated use.

  • Warnings  

    For external use only.

    Flammable. Keep away from fire or flame.

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

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • place enough product into your palms and thoroughly spread on both hands.
    • rub into skin until dry.

  • Keep out of reach of children

    Children must be supervised in use of this product.

  • Other information

    • store below 110℉ (43℃).
    • may discolor certain fabrics or surfaces.

  • Inactive ingredient

    carbomer, triethanolamine, glycerin, water.

  • Product labels

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DR.DAVEY 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74913-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74913-001-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
    2NDC:74913-001-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2020
    Labeler - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD546345856manufacture(74913-001)