Label: POMEGRANATE AND VANILLA SCENTED HAND SANITIZER- alcohol gel

  • NDC Code(s): 80684-032-01
  • Packager: FOURSTAR GROUP USA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol, 70% v/v

    Purpose

    Antimicrobial

  • Uses

    hand sanitizer to help reduce bacteria on skin

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation, excessive redness or rash develops.

    Keep out of reach of children.

    Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Put a dime sized drop onto hands and rub together briskly until dry.

  • Other information

    Store below 110°F (43°C)

  • Inactive ingredients

    water, glycerin, propylene glycol, carbomer, fragrance, triethanolamine, red 4

  • Package Labeling:

    Bottle3Box3

  • INGREDIENTS AND APPEARANCE
    POMEGRANATE AND VANILLA SCENTED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-032-011 in 1 BOX06/10/2021
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/10/2021
    Labeler - FOURSTAR GROUP USA, INC. (140099503)
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