Label: OPSONAT- silver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering top solution/ drops

  • NDC Code(s): 59469-313-10, 59469-313-40
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 11, 2023

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  • ACTIVE INGREDIENT

    Ingredients:
    Acidum nitricum6X
    Acidum sulfuricum6X
    Gratiola officinalis4X
    Hydrastis canadensis5X
    Lachesis muta8X
    Lytta vesicatoria (Cantharis)4X
    Bellis perennis1X
    Glechoma hederacea16.02 mg/ml

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 24% alcohol by volume.

  • Indications

    For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

    OPSONAT™

    Oral Drops

    Homeopathic Medicine

    For relief of minor
    mucous membrane
    inflammation, such
    as the mouth

    3.34 FL OZ
    (100 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    OPSONAT 
    silver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering top solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-313
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_X]  in 100 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID6 [hp_X]  in 100 mL
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS WHOLE - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE1 [hp_X]  in 100 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA4 [hp_X]  in 100 mL
    GRATIOLA OFFICINALIS WHOLE (UNII: BDD9991A36) (GRATIOLA OFFICINALIS WHOLE - UNII:BDD9991A36) GRATIOLA OFFICINALIS WHOLE4 [hp_X]  in 100 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 100 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM8 [hp_X]  in 100 mL
    GLECHOMA HEDERACEA FLOWERING TOP (UNII: 2458J91U39) (GLECHOMA HEDERACEA FLOWERING TOP - UNII:2458J91U39) GLECHOMA HEDERACEA FLOWERING TOP1602 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-313-401 in 1 BOX06/24/2019
    1100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:59469-313-101 in 1 BOX06/24/2019
    250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/24/2019
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-313)
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