Label: BI FU JIAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER SPRAYS FOR RHINITIS- high-efficiency anti-bacteria monomer silver sprays for rhinitis liquid

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 8, 2016

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  • Active ingredient

    Silver content: 100 μg/mL, 1500 μg/15mL

  • Purpose

    Acute rhinitis; chronic rhinitis; rhinobyon, rhinalgia, dry and itchy nose, nasal congestion, rhinorrhea, sneeze.

  • Indcations and usage

    Acute rhinitis; chronic rhinitis; rhinobyon, rhinalgia, dry and itchy nose, nasal congestion, rhinorrhea, sneeze.

    Topical use: Spraying into the nasal cavity.

  • Dosage

    4 sprays each time and 3 times each day, for 7 consecutive days, or longer if serious.

    4 times each day for chronic rhinitis patient, for 7 consecutive days, or longer if serious.

  • Warnings

    Contraindications:
    1, Not for virgins.
    2, Do not use if allergic to silver.
    3, Pregnant women shall follow doctor advice.
    Notes:
    1, Do not use if package is broken; do not use with medicine that contains Vaseline, chlorine, iodine or hydrogen peroxide.
    2, This product is for external use only; do not take in.
    3, Keep away from clothes to prevent contamination.

  • Out of children

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

  • Inactive ingredient

    Sodium chloride: 20000 μg/15mL

    Water: 14978500 μg/15mL

  • Label

    Package label

    Package label

    Carton label

    Carton label

  • INGREDIENTS AND APPEARANCE
    BI FU JIAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER SPRAYS FOR RHINITIS 
    high-efficiency anti-bacteria monomer silver sprays for rhinitis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60659-0303
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER1500 ug  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 20000 ug  in 15 mL
    WATER (UNII: 059QF0KO0R) 14978500 ug  in 15 mL
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60659-0303-11 in 1 CARTON
    1NDC:60659-0303-015 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/08/2016
    Labeler - Bang An Bao Medical Equipment Co., Ltd. (421323212)
    Registrant - Bang An Bao Medical Equipment Co., Ltd. (421323212)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bang An Bao Medical Equipment Co., Ltd.421323212label(60659-0303) , manufacture(60659-0303)
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