CANDIDA (CANDIDA PARAPSILOSIS) SPRAY [BIORESOURCE INC.]

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CANDIDA (CANDIDA PARAPSILOSIS) SPRAY [BIORESOURCE INC.]
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NDC 54256-099-05
Set ID 872f851f-6f84-4263-9b7b-e0833a97f941
Category HUMAN OTC DRUG LABEL
Packager BioResource Inc.
Generic Name
Product Class
Product Number
Application Number
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  • Indications

    For relief of yeast infections.

  • Dosage

    Spray twice into each nostril three times daily.

  • Ingredients

    15ml Candida parapsilosis 4X in a base of purified water, 0.135g sodium chloride, 0.015g potassium sorbate.

  • Warning

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all medications out of the reach of children. Protect from light and heat.

  • Tamper Evident

    Do not use product if tamper evident strip is broken.

  • QUESTIONS

    To report adverse events, contact BioResource at 707/664-9023 or bioresource2@prodigy.net

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati CA 94931

  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle Box

    SanPharma™
    Candida
    Nasal-Spray 4X

    Homeopathic
    Medicine
    For yeast infections

    RX

    0.51 FL OZ
    (15ml)

    SanPharma™

    PRINCIPAL DISPLAY PANEL - 15 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    CANDIDA 
    candida parapsilosis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54256-099
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Candida parapsilosis (UNII: 0KZ676D44N) (Candida parapsilosis - UNII:0KZ676D44N) Candida parapsilosis4 [hp_X]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium chloride (UNII: 451W47IQ8X)  
    Potassium sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54256-099-051 in 1 BOX08/01/2016
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/2016
    Labeler - BioResource Inc. (017532917)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sophien Arzneimittel GmbH537313459MANUFACTURE(54256-099)
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