The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Dentastat (NDC 44911-0661). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purposes:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each drop) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.
Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May temporarily relieve symptoms associated with dental procedures, such as pain and minor swelling in the mouth or on the gums.**
** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Stop use and ask a doctor if symptoms persist for more than 7 days.
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.
• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.
• Consult a physician for use in children under 12 years of age.
Demineralized water, 20% Ethanol.
Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579
800.869.8078
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
DENTASTAT
1 fl. oz. (30 ml)
* Please review the disclaimer below.
