Label: SHEA BUTTER SCENTED HAND SANITIZER- alcohol liquid

  • NDC Code(s): 80684-122-00
  • Packager: FOURSTAR GROUP USA, INC.
  • 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, 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.

    If swallowed, get medical help 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, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol

  • Package Labeling:

    Outer Package3Inner Package3

  • INGREDIENTS AND APPEARANCE
    SHEA BUTTER SCENTED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-122
    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)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-122-0089 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2023
    Labeler - FOURSTAR GROUP USA, INC. (140099503)
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