Label: HBA ANTI BACTERIAL LIQUID- polihexanide spray

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

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Drug Label Information

Updated July 22, 2020

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  • Active Ingredient

    Polyhexamethylene biguanide 0.2% w/w

    Purpose

    Antibacterial

  • Use

    ■ Skin disinfection

  • WARNINGS

    For external use only

    Do not use if you are allergic to any ingredients listed

    Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

    Do not get into eyes. Rinse thoroughly with water if contact occurs

    keep out of reach of children

    Keep out of reach of children. If swallowed, see a doctor or contact a poison control center immediately

  • Directions

    Spray the product directly on the skin, no need to wash

    Immerse a piece of gauze in the disinfectant, then wipe the site of action repeatedly or do wet compress

    When disinfect the objects which have direct contact with skin, just spray the product directly

  • Inactive ingredients

    Water, Glycerol

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HBA ANTI BACTERIAL LIQUID 
    polihexanide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79158-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79158-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/22/2020
    Labeler - Henan Huibo Medical Co., Ltd. (560455084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Huibo Medical Co., Ltd.560455084manufacture(79158-003)
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