OPSONAT: Homeopathic Product Information

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

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.

Ingredients:
Acidum nitricum	6X
Acidum sulfuricum	6X
Gratiola officinalis	4X
Hydrastis canadensis	5X
Lachesis muta	8X
Lytta vesicatoria (Cantharis)	4X
Bellis perennis	1X
Glechoma hederacea	16.02 mg/ml

Selected ingredients prepared by spagyric processes.

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.

Protect from light and heat.

Tamper Evident

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

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

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^®

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59469-313 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (SILVER CATION) SILVER NITRATE 6 [hp_X] in 100 mL SULFURIC ACID (SULFURIC ACID) SULFURIC ACID 6 [hp_X] in 100 mL BELLIS PERENNIS WHOLE (BELLIS PERENNIS WHOLE) BELLIS PERENNIS WHOLE 1 [hp_X] in 100 mL LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 4 [hp_X] in 100 mL GRATIOLA OFFICINALIS WHOLE (GRATIOLA OFFICINALIS WHOLE) GRATIOLA OFFICINALIS WHOLE 4 [hp_X] in 100 mL GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 5 [hp_X] in 100 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 8 [hp_X] in 100 mL GLECHOMA HEDERACEA FLOWERING TOP (GLECHOMA HEDERACEA FLOWERING TOP) GLECHOMA HEDERACEA FLOWERING TOP 1602 mg in 100 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59469-313-40 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 1 100 mL in 1 BOTTLE, GLASS This package is contained within the BOX (59469-313-40) 2 NDC:59469-313-10 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS 2 50 mL in 1 BOTTLE, GLASS This package is contained within the BOX (59469-313-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 06/24/2019

Labeler — PEKANA Naturheilmittel GmbH (320344542)

Establishment
Name	Address	ID/FEI	Operations
PEKANA Naturheilmittel GmbH		320344542	MANUFACTURE (59469-313)

Revised: 01/2023 PEKANA Naturheilmittel GmbH