Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 82321547-e04a-42ff-aa39-6a192638e5a2
Route
ORAL
Published
Effective Date 2017-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Antimony Trisulfide (12 [hp_X]) Atropa Belladonna (30 [hp_X]) Oyster Shell Calcium Carbonate, Crude Fluoride Ion Calcium Cation Hekla Lava Mercurius Solubilis Lead Sepia Officinalis Juice Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-09-10

Description

Antimonium Crudum 12X, Belladonna 12X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 12X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Sepia 12X, Silicea 12X, Hydrofluoricum Acidum 30X.


Medication Information

Description

Antimonium Crudum 12X, Belladonna 12X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 12X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Sepia 12X, Silicea 12X, Hydrofluoricum Acidum 30X.

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 gum, dentition, and tooth pain.

Active Ingredients:

Antimonium Crudum 12X, Belladonna 12X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 12X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Sepia 12X, Silicea 12X, Hydrofluoricum Acidum 30X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Display Label:

​BioActive Homeopathic

​DENTAFORCE

​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

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 gum, dentition, and tooth pain.

Active Ingredients: (ACTIVE INGREDIENTS:)

Antimonium Crudum 12X, Belladonna 12X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 12X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Sepia 12X, Silicea 12X, Hydrofluoricum Acidum 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Display Label: (PACKAGE DISPLAY LABEL:)

​BioActive Homeopathic

​DENTAFORCE

​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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