Label: HAND SANITIZER- alcohol liquid

  • 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 December 17, 2021

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  • ACTIVE INGREDIENT

    Ethyl Alcohol (63%)

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    For external use only. Do not use in or near the eyes. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away. Flammable-keep away from open flame.

  • INACTIVE INGREDIENT

    Water, Glycerin, Aloe Vera Leaf Extract, Citrus Peel Extract

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

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

  • PRINCIPAL DISPLAY PANEL

    nat san

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL630 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-130-018 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/08/2014
    Labeler - Bullet Line, LLC (122539042)