Label: NOTATUM-QUENTANS NASAL 4X- penicillium chrysogenum var. chrysogenum and penicillium glabrum 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 January 26, 2016

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  • PURPOSE

    Indications

    For relief of minor cold symptoms and nasal congestion.

  • Dosage

    Spray twice into each nostril three times daily.

  • ACTIVE INGREDIENT

    Ingredients

    10 ml Penicillium notatum (chrysogenum) 4X and Penicillium frequentans 4X in a base of purified water, 0.09g sodium chloride, 0.01g 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.

    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 - 10 ml Bottle Box

    SanPharma™
    Notatum-Quentans
    Nasal-Spray 4X

    Homeopathic
    Medicine

    For nasal congestion

    RX

    0.34 FL OZ
    (10ml)

    SanPharma ™

    PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    NOTATUM-QUENTANS NASAL 4X 
    penicillium chrysogenum var. chrysogenum and penicillium glabrum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54256-046
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Penicillium Chrysogenum Var. Chrysogenum (UNII: 3Y1PE1GCIG) (Penicillium Chrysogenum Var. Chrysogenum - UNII:3Y1PE1GCIG) Penicillium Chrysogenum Var. Chrysogenum4 [hp_X]  in 10 mL
    Penicillium Glabrum (UNII: 2IN23YUE0I) (Penicillium Glabrum - UNII:2IN23YUE0I) Penicillium Glabrum4 [hp_X]  in 10 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:54256-046-051 in 1 BOX
    110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2016
    Labeler - BioResource Inc. (017532917)
    Establishment
    NameAddressID/FEIBusiness Operations
    RubiePharm Arzneimittel GmbH313767774MANUFACTURE(54256-046)
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