Label: SALVATION HANDS DISINFECTANT WIPES- benzalkonium chloride cloth

  • 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 November 19, 2020

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  • DRUG FACTS

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial

  • Uses

    • Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
  • Warnings:

    For external use only.

    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.

  • Directions:

    • Use wipes to disinfectant hands or surfaces. 
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Inactive Ingredients:

    Water, Glycerin, Ethylhexylglycerin, Phenoxyethanol, Didecyldimonium Chloride, Alcohol, Propylene Glycol
    www.salvationhands.com

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    SALVATION HANDS DISINFECTANT WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79915-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79915-001-01100 in 1 CANISTER11/30/2020
    15.4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/30/2020
    Labeler - E-Liquids Investment Group LLC (080384210)
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