Label: CANDIDA- candida parapsilosis spray

  • 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 September 2, 2016

If you are a consumer or patient please visit this version.

  • 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)