Label: HAND SANITIZER GEL- hand sanitizer 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 May 13, 2020

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  • Active ingredient

    Alcohol 75% v/v (ethanol)

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • In children less than 2 months of age
    • On open skin wounds

    Stop use and ask a doctor

    if irritation or rash occurs.

    When using this product

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Keep out of reach of children,

    in case of swallowed,get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces.Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 5-30 C (59-86F)
    • Avoid freeezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Extract, Centella Asiatice Extract, Forsythia Suspensa Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Propolis Extract, Fragrance

  • Questions?

    Questions? 123-555-1234

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Hand sanitizer gel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77314-688
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)  
    WATER (UNII: 059QF0KO0R)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77314-688-68500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Guangzhou Chuyu Cosmetics Co., Ltd. (418751396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Chuyu Cosmetics Co., Ltd.418751396manufacture(77314-688)
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