Label: MYREMEDE SANITIZING 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 August 3, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Use

    Sanitizing wipes designed to help reduce bacteria when soap and water are not available or practical.

  • Warnings

    For external use only. For single and non-medical use only. Appropriately dispose of used wipes.

    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 consult a doctor if

    irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • Apply topicall as needed to intended surfaces. Let air dry.
    • Supervise children under 6 years of age when using this product to avoid choking.
    • Please keep sealed between uses to maintain adequate moisture.
    • Do not flush wipes.
  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Pure water, Didecyldimethylammonium chloride, 2-Phenoxyethanol, 3-[2-(Ethylhexyloxy]-1,2-propanediol, 1,2-Propanediol, Glycerol

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MYREMEDE SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77529-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77529-001-5050 in 1 PACKAGE07/10/2020
    14.728 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 finalpart333E07/10/2020
    Labeler - Remede Organics, Inc (117506657)
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