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

----------

Drug Facts:

ACTIVE INGREDIENTS:

(in each drop): 9.06% of Argentum Metallicum 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Iodium 12X, Mercurius Solubilis 12X, Niccolum Metallicum 12X, Phytolacca Decandra 6X, Platinum Metallicum 16X, Silicea 12X, Zincum Metallicum 12X; 0.10% of Allium Sativum 3X, Berberis Vulgaris 3X, Fucus Vesiculosus 3X.

INDICATIONS:

May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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:

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

DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DENTASTAT

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, silicea, zincum metallicum, platinum metallicum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC3 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_X]  in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE12 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267) NICKEL12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM16 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0555-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/12/202008/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/202008/25/2025
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0555) , api manufacture(44911-0555) , label(44911-0555) , pack(44911-0555)

Revised: 10/2022
Document Id: cd186625-adaf-4614-abb3-6d10ddfd1956
Set id: acfadaf0-60e4-4268-8b5b-8d26fdd871d7
Version: 2
Effective Time: 20221011
 
Energique, Inc.