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Drug Facts:

SPL v7

SPL

SPL Set ID 12f1ef62-93f3-45b8-885d-1b82f85a8355

Route

ORAL

Published

Effective Date 2017-04-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Atropa Belladonna (30 [hp_X]) Conium Maculatum Flowering Top (30 [hp_C]) Solanum Dulcamara Top Calcium Sulfide Dichromate Ion Mercurius Solubilis Anemone Pulsatilla Silicon Dioxide Matricaria Recutita

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2012-07-13

Description

Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

Medication Information

Description

Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

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 symptoms due to inflammation of the ear.

Active Ingredients:

Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

OTOFLAM HP

HOMEOPATIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

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

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 symptoms due to inflammation of the ear.

Active Ingredients: (ACTIVE INGREDIENTS:)

Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

OTOFLAM HP

HOMEOPATIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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

Advanced Ingredient Data

[{"name": "ATROPA BELLADONNA", "unii": "WQZ3G9PF0H", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CONIUM MACULATUM FLOWERING TOP", "unii": "Q28R5GF371", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SOLANUM DULCAMARA TOP", "unii": "KPS1B1162N", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CALCIUM SULFIDE", "unii": "1MBW07J51Q", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DICHROMATE ION", "unii": "9LKY4BFN2V", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MERCURIUS SOLUBILIS", "unii": "324Y4038G2", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ANEMONE PULSATILLA", "unii": "I76KB35JEV", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MATRICARIA RECUTITA", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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 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 symptoms due to inflammation of the ear.", "ACTIVE INGREDIENTS:": "Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.", "INACTIVE INGREDIENTS:": "Demineralized Water, 25% Ethanol.", "PACKAGE LABEL DISPLAY:": "BIO Active Nutritional OTOFLAM HP HOMEOPATIC 1 FL OZ (30 ml)", "KEEP OUT OF REACH OF CHILDREN:": "10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:42.798281 · Updated: 2026-03-14T23:14:40.993611