Label: MODAKA WIPE ME- benzalkonium chloride cloth

  • NDC Code(s): 77586-002-01
  • Packager: DERMA INNOVATION COMPANY LIMITED
  • 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 September 16, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Use

      decrease bacteria on skin untitled

  • Warnings

    For external use only

    Do not use if you are allergic to any of the ingredients

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

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

  • Directions

    Open the lid, tear the seal sticker, take out the wipes, adults and children 2 years and over, apply to hands

    untitled

  • Inactive ingredients

    Water (Aqua), Phenoxyethanol, Sodium Benzoate, PEG-40 Hydrogenated Castor Oil, Citric Acid

  • SPL UNCLASSIFIED SECTION

    99.9%

    Effective Disinfection

    Sterilization

    STRONG STERILIZATION PROTECT HEALTH

    Clean 

    Gentle 

    Moisturizer 

    Soft

    Made in Thailand

    Distributed by:

    Chintamonwatchara Group Company Limited, 30 Floors

    Bhiraj Tower, 689 Sukhumvit Road (Soi 35), Klongtan Nuea, Vadhana Bangkok 10110

  • Packaging

    IMAGE

    IMAGEIMAGE

    untitled

  • INGREDIENTS AND APPEARANCE
    MODAKA WIPE ME 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77586-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77586-002-0160 in 1 PACKAGE09/16/2020
    13.15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/16/2020
    Labeler - DERMA INNOVATION COMPANY LIMITED (662350322)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMA INNOVATION COMPANY LIMITED662350322manufacture(77586-002)