Label: 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 10, 2020

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  • Purpose

    Purpose Antiseptic

  • WHEN USING SECTION

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

  • ACTIVE INGREDIENT

    Active ingrendient Benzalkonium Chloride 0.3%

  • OTC- KEEP OUT OF REACH OF CHILDREN

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

  • STOP USE

  • Use

    Uses Hand Sanitizer to help reduce bacteria that potentially can cause disease. Foruse when soap and water are not available

  • Warnings

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

  • Do not use section

    in children less than 2 months of ageon open skin wounds

  • STORAGE AND HANDLING

    Other information STORAGE AND HANDLING SECTIONJEDITStore between 15-30C(59-86P)Avoid freezing and excessive heat ab

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands togetheruntil drySupervise children under 6 years of age when using this product to avoidngOther information STORAGE AND HANDLING SECTIONJEDITStore between 15-30C(59-86P)Avoid freezing and excessive heat above 40C(104P)

  • INACTIVE INGREDIENT

    Water, Glycerin, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor OilPhenoxyethanol, Aloe Barbadensis Leaf Juice, Butylene Glycol, Fragrance

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76526-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL DICAPRYLATE (UNII: 13P836X9Q6)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76526-005-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Xiamen Cleanss Daily Chemical Co.，Ltd. (546469556)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Cleanss Daily Chemical Co.，Ltd.546469556manufacture(76526-005)
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