Label: HAND SANITIZER WATERMELON- 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 August 10, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    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 of 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 between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    Carbomer, Denatonium Benzoate, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Propylene Glycol, Sodium Hydroxide, Water.

  • Questions?

    CHEMTREC(contracted consultant):1-800-424-9300

  • Package Labeling:

    Bottle16

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WATERMELON 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79834-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79834-115-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/15/2020
    Labeler - Lemontree ICS (117589151)
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