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Drug Facts:

SPL v1

SPL

SPL Set ID f39c9feb-f567-43a2-a026-2a581aeeed9d

Route

ORAL

Published

Effective Date 2016-07-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arnica Montana (3 [hp_X]) Trifolium Pratense Flower (12 [hp_X]) Oyster Shell Calcium Carbonate, Crude Fluoride Ion Calcium Cation Matricaria Recutita Wood Creosote Silicon Dioxide

Inactive Ingredients

Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2016-07-27

Description

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

Medication Information

Description

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

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 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 due to teething and delayed teething.

Active Ingredients:

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

Inactive Ingredients:

Demineralized water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

TEETHING

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

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 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 due to teething and delayed teething.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

TEETHING

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

[{"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "TRIFOLIUM PRATENSE FLOWER", "unii": "4JS0838828", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIM", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MATRICARIA RECUTITA", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "WOOD CREOSOTE", "unii": "3JYG22FD73", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 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 due to teething and delayed teething.", "ACTIVE INGREDIENTS:": "Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X", "INACTIVE INGREDIENTS:": "Demineralized water, 25% Ethanol", "PACKAGE LABEL DISPLAY:": "BIO Active Nutritional TEETHING 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:39.569625 · Updated: 2026-03-14T23:14:38.618679