DENTASTAT- allium sativum, berberis vulgaris, fucus vesiculosus, phytolacca decandra, argentum metallicum, aurum metallicum, calcarea fluorica, calcarea phosphorica, iodium, mercurius solubilis, niccolum metallicum, platinum metallicum, silicea, zincum metallicum liquid
Apotheca Company

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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Dentastat

ACTIVE INGREDIENTS: Allium sativum 3X, Berberis vulgaris 3X, Fucus vesiculosus 3X, Phytolacca decandra 3X, Argentum metallicum 12X, Aurum metallicum 12X, Calcarea fluorica 12X, Calcarea phosphorica 12X, Iodium 12X, Mercurius solubilis 12X, Niccolum metallicum 12X, Platinum metallicum 12X, Silicea 12X, Zincum metallicum 12X.

INDICATIONS: For temporary relief of pain and minor inflammation in the mouth, or on the gums following dental procedures.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

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

SUGGESTED USE: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS: For temporary relief of pain and minor inflammation in the mouth, or on the gums following dental procedures.

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol

Dist. By:

Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

ENERGIQUE

DENTASTAT

Homeopathic Remedy

1 fl. oz. (30 ml)

Dentastat

DENTASTAT
allium sativum, berberis vulgaris, fucus vesiculosus, phytolacca decandra, argentum metallicum, aurum metallicum, calcarea fluorica, calcarea phosphorica, iodium, mercurius solubilis, niccolum metallicum, platinum metallicum, silicea, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	3 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [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
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	12 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267)	NICKEL	12 [hp_X] in 1 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY)	PLATINUM	12 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	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:57520-0435-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/21/2010	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/21/2010	09/08/2022

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0435) , api manufacture(57520-0435) , label(57520-0435) , pack(57520-0435)

Revised: 4/2022

Document Id: 16995a8d-c0e7-4502-b7b8-b5cba7048e84

Set id: 3ec9b19e-a175-4ba5-b551-d1921f91dc54

Version: 2

Effective Time: 20220406

Apotheca Company