Label: ALOE HAND SANITIZER- alcohol 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 July 21, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL DENAT. 62% w/w

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine, Hydroxyacetophenone, Fragrance, Ethylhexylglycerin, Trehalose, Hamamelis Virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Water, 1,2-Hexanediol, Sodium Hyaluronate, Linalool, Hexyl Cinnamal

  • PURPOSE

    Antimicrobial

  • 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
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Hand gel that kills germs that can potentially cause disease.

  • Directions

    Dispense an appropriate product onto the palm of hands. Rub hands together until dry.

  • Other Information

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    ALOE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-807
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Trehalose (UNII: B8WCK70T7I)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-807-0150 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 finalpart333E07/01/2020
    Labeler - TONYMOLY CO., LTD. (688216798)
    Registrant - TONYMOLY CO., LTD. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEGACOS MANUFACTURING Co., Ltd.694745986manufacture(59078-807)
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