Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID dbe965b3-e81e-4328-bc41-43e875e12a05
Route
ORAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Berberis Vulgaris Root Bark (3 [hp_X]) Glycyrrhiza Glabra (4 [hp_X]) Arctium Lappa Root (8 [hp_X]) Stillingia Sylvatica Root (12 [hp_X]) Trifolium Pratense Flower Phytolacca Americana Root Sus Scrofa Lymph Sus Scrofa Bone Marrow Sus Scrofa Thymus Sus Scrofa Thyroid Fluoride Ion Silver Gold Copper Eugenol Formaldehyde Solution Lidocaine Mercurius Solubilis Molybdenum Nickel Palladium Tin Titanium Zinc
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-14

Description

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X,Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

Purpose

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


Medication Information

Purpose

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

Description

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X,Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

Purpose:

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

Warnings:

If pregnant or breast-feeding, ask a health care 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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

10 drops orally, 3 times a day. 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 gums following dental procedures.

Active Ingredients:

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X,Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

DENTOX

HOMEOPATHIC

1 FL OZ (30 ml)

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.


Structured Label Content

Purpose: (PURPOSE:)

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

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care 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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X,Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

DENTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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