Label: DISINFECTING WIPES cloth

  • NDC Code(s): 55485-003-01
  • Packager: Reynard (Ningbo) Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 29, 2020

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  • DOSAGE & ADMINISTRATION

    Store below 110°F (43°0C)

  • INACTIVE INGREDIENT

    Purified water

    Spunlace non-woven

  • INDICATIONS & USAGE

    Wipe hand with wipe. Let air dry. Discard used wipe in trash. Do not flush in tilet.

  • ACTIVE INGREDIENT

    phenoxyethanol

    Ethylhexylglycerin

    Benzalkonium chloride

    DDAC

    Propylene glycol

    glycerin

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.Flammable. Keep away from fire or flame.For external use only.
    2.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if iritation or rash appears and lasts.
    3.Keep out of reach of children. If swallowed, get medical help right away.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    disinfecting wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55485-003
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 160 
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.12 g  in 160 
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.12 g  in 160 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.6 g  in 160 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.12 g  in 160 
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.24 g  in 160 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code TMD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55485-003-01160 in 1 PACKET; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2020
    Labeler - Reynard (Ningbo) Biotechnology Co., Ltd. (554529764)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reynard (Ningbo) Biotechnology Co., Ltd.554529764manufacture(55485-003)
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