HAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]

HAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]
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NDC 19392-110-01, 19392-110-03, 19392-110-05
Set ID cfd91c0e-9af9-4970-abf6-ed8e0a1b6460
Category HUMAN OTC DRUG LABEL
Packager Bullet Line, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Alcohol (62%)

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    For external use only

    Do not use in or near the eyes

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children

    If swallowed, contact a doctor or Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping

  • INACTIVE INGREDIENT

    Water, Hydrogenated starch, Carbomer, Tetrahydroxypropyl Ethylenediamine, Fragrance

  • PRINCIPAL DISPLAY PANEL

    331 Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ETHYLENEDIAMINE CARBAMATE (UNII: 5823XF90GJ)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-110-018 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2010
    Labeler - Bullet Line, LLC (122539042)

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