Label: PHMB DISINFECTANT spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 22, 2020

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  • DOSAGE & ADMINISTRATION

    Store in a cool and dry place

  • INACTIVE INGREDIENT

    Water, Glycerol, Sodium Hyaluronate

  • INDICATIONS & USAGE

    Shake Well Before Use, Spray Directly on the Object to be Disinfected

  • ACTIVE INGREDIENT

    PHMB

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    External Use Only, Keep out of Reach of Children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PHMB DISINFECTANT 
    phmb disinfectant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55262-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE HYDROCHLORIDE3.5 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code PHMB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55262-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/22/2020
    Labeler - Ugel Pharm Tech (Shanghai) Co., Ltd. (552624531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ugel Pharm Tech (Shanghai) Co., Ltd.552624531manufacture(55262-001)