ORATOX- fucus vesiculosus, lymph node (suis), medulla ossis suis, thymus (suis), thyroidinum (suis), calcarea muriatica, iodium, natrum fluoratum, natrum muriaticum, selenium metallicum, vanadium metallicum, argentum metallicum, aurum metallicum, cuprum metallicum, eugenol, formalinum, lidocaine, mercurius solubilis, molybdenum metallicum, niccolum metallicum, palladium metallicum, stannum metallicum, titanium metallicum, zincum metallicum liquid
Deseret Biologicals, Inc.

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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Calcarea Muriatica 12X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Fucus Vesiculosus 3X, Iodium 12X, Lidocaine 12X, 30X, 60X, 200X, Lymph Node (Suis) 8X, Medulla Ossis Suis 8X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum 12X, 30X, 60X, 200X, Natrum Fluoratum 12X, Natrum Muriaticum 12X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Selenium Metallicum 12X, Stannum Metallicum 12X, 30X, 60X, 200X, Thyroidinum (Suis) 8X, Thymus (Suis) 8X, Titanium Metallicum 12X, 30X, 60X, 200X, Vanadium Metallicum 12X, Zincum Metallicum 12X, 30X, 60X, 200X.

PURPOSE:

Argentum Metallicum – Muscle Cramps, Aurum Metallicum - Inflammation, Calcarea Muriatica – Joint Pain, Cuprum Metallicum – Muscle Cramps, Eugenol - Inflammation, Formalinum - Inflammation, Fucus Vesiculosus – Joint Pain, Iodium - Inflammation, Lidocaine – Joint Pain, Lymph Node (Suis) - Inflammation, Medulla Ossis Suis – Muscle Cramps, Mercurius Solubilis – Joint Pain, Molybdenum – Muscle Cramps, Natrum Fluoratum - Inflammation, Natrum Muriaticum – Joint Pain, Niccolum Metallicum - Inflammation, Palladium Metallicum - Inflammation, Selenium Metallicum – Joint Pain, Stannum Metallicum – Muscle Cramps, Thyroidinum (Suis) - Inflammation, Thymus (Suis) - Inflammation, Titanium Metallicum – Muscle Cramps, Vanadium Metallicum - Inflammation, Zincum Metallicum – Joint Pain

USES:

• For the temporary relief of symptoms including:

• muscle cramps • inflammation • joint pain

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070

www.desbio.com

800-827-8204

PACKAGE LABEL DISPLAY:

DesBio

Oratox

Homeopathic

NDC 43742-0944-1

1 FL OZ (30 ml)

Oratox

ORATOX
fucus vesiculosus, lymph node (suis), medulla ossis suis, thymus (suis), thyroidinum (suis), calcarea muriatica, iodium, natrum fluoratum, natrum muriaticum, selenium metallicum, vanadium metallicum, argentum metallicum, aurum metallicum, cuprum metallicum, eugenol, formalinum, lidocaine, mercurius solubilis, molybdenum metallicum, niccolum metallicum, palladium metallicum, stannum metallicum, titanium metallicum, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43742-0944
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X] in 1 mL
SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L)	SUS SCROFA LYMPH	8 [hp_X] in 1 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8)	SUS SCROFA BONE MARROW	8 [hp_X] in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	8 [hp_X] in 1 mL
THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	THYROID	8 [hp_X] in 1 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CHLORIDE	12 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	12 [hp_X] in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	12 [hp_X] in 1 mL
VANADIUM (UNII: 00J9J9XKDE) (VANADIUM - UNII:00J9J9XKDE)	VANADIUM	12 [hp_X] in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	12 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	12 [hp_X] in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	12 [hp_X] in 1 mL
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	12 [hp_X] in 1 mL
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525)	FORMALDEHYDE	12 [hp_X] in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	12 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	12 [hp_X] in 1 mL
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267)	NICKEL	12 [hp_X] in 1 mL
PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M)	PALLADIUM	12 [hp_X] in 1 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	12 [hp_X] in 1 mL
TITANIUM (UNII: D1JT611TNE) (TITANIUM - UNII:D1JT611TNE)	TITANIUM	12 [hp_X] in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43742-0944-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	12/27/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/27/2016

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43742-0944) , api manufacture(43742-0944) , label(43742-0944) , pack(43742-0944)