HAND SANITIZER (ALCOHOL) GEL [CMC GROUP INC.]

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HAND SANITIZER (ALCOHOL) GEL [CMC GROUP INC.]
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NDC 49687-0015-0
Set ID dcca50e6-0935-401d-a23e-be4d1231dde9
Category HUMAN OTC DRUG LABEL
Packager CMC Group Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.
  • Warnings

    Flammable, keep away from fire or flame

    For external use only.

    Do not use

    • in the eyes.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    Store at 15° to 25°C (59° to 77°F)

  • Inactive ingredients

    Carbomer, propylene glycol, purified water, titanium dioxide

  • Package Labeling

    49687-0015-049687-0015-1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0015-16 in 1 BOX08/08/2016
    10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:49687-0015-06 in 1 KIT08/08/201608/08/2016
    20.9 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/08/2016
    Labeler - CMC Group Inc. (117201448)
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