Label: HAND SANITIZER- ethyl alcohol spray

  • 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 30, 2020

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  • Active Ingredient

    Ethyl Alcohol 71%

    Purpose

    Antiseptic

  • USE

    Hand sanitizing to help reduce bacteria on the skin. Recommended for repeated use.

  • Warning

    For external use only./ Para uso externo uinicamente.
    Do not use / No utilice o lf you are allergic to any of the ingredients. o In the eyes;if contact occurs, rinse thoroughly with water.i Si es alergico a alguno de losingredientes.· Si entra en contacto con los ojos,enjuague por completo con agua.Discontinue use ifiritation and redness develop. lf condition persists for morethan 72 hours consult a doctor./Suspenda el uso si se presenta irritacion yenrojecimiento.Consulte a un medico si la condicion persiste por mas de 72 horas.Keep out of reach of children. If swallowed, get medical help or contact aPoison Control Center right away./ Mantengase fuera del alcance de los niios.Sise ingiere, obtenga atencion medica o pongase en contacto de inmediato conun Centro de control de envenenamientos.

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

  • Directions

    Adtults and children 2 yrs and over, apply to hands and allow skin to dry without wiping. Children under 2, ask doctor before use.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, TocopheryI Acetate (Vitamin E), Triethanolamine, Water(Aqua).

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-018-0130 in 1 CARTON12/30/2020
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc. 421280161manufacture(77720-018)
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