Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 767f8dd2-759f-4662-9b5c-b8832309363d
Route
ORAL
Published
Effective Date 2022-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_C]) Hypericum Perforatum (4 [hp_C]) Plantago Major (6 [hp_C]) Aconitum Napellus Mercurius Solubilis Hekla Lava Silver Cation Atropa Belladonna Calcium Sulfide Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2022-02-14 Until 2027-03-04

Description

Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.


Medication Information

Description

Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.

Questons:

MFD FOR: The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

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.

Directions:

Spray orally, 2 to 4 sprays twice daily on affected teeth or gums, at least 30 minutes before or after eating. Consult a physician for use in children under 12 years of age.

Indications:

For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body's natural slowing of excess bleeding. Promotes healthy gums.

Active Ingredients:

Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.

Inactive Ingredients:

Demineralized Water, 25% Organic Ethanol.

Package Label Display:

Dr. Theresa Dale's

NDC 50181-0082-1

Homeopathic

BioTox 

Dental Foci

Repair

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

Questons: (QUESTONS:)

MFD FOR: The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

Warnings: (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.

Directions: (DIRECTIONS:)

Spray orally, 2 to 4 sprays twice daily on affected teeth or gums, at least 30 minutes before or after eating. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body's natural slowing of excess bleeding. Promotes healthy gums.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Organic Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Dr. Theresa Dale's

NDC 50181-0082-1

Homeopathic

BioTox 

Dental Foci

Repair

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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