Label: HAND SANITIZER- 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 January 8, 2021

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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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