Arnica Montana 30c

SPL v3

SPL

SPL Set ID bfbe4b3b-beed-4187-b82b-dc6dde07d91e

Route

ORAL

Published

Effective Date 2022-02-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arnica Montana (30 [hp_C])

Inactive Ingredients

Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2006-07-01

Description

ACTIVE INGREDIENT (HPUS*): Arnica Montana 30C

Medication Information

Warnings and Precautions

WARNINGS:

Consult a physician for use in children under 12 years of age.
IF PREGNANT OR BREAST-FEEDING, ask as health care professional before use.
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Do not use if TAMPER EVIDENT seal is broken or missing.

Indications and Usage

USES: Temporarily relieves aches, pains and bruising.**

Dosage and Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Description

ACTIVE INGREDIENT (HPUS*): Arnica Montana 30C

Section 34093-5

* The letters "HPUS" indicate the component in the product is officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.

Section 51945-4

NDC: 43406-0217-1

ARNICA MONTANA 30C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves aches, pains and bruising.**

Section 55106-9

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 30C

Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves aches, pains and bruising.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Warnings and Precautions (34071-1)

WARNINGS:

Consult a physician for use in children under 12 years of age.
IF PREGNANT OR BREAST-FEEDING, ask as health care professional before use.
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Do not use if TAMPER EVIDENT seal is broken or missing.

Section 34093-5 (34093-5)

* The letters "HPUS" indicate the component in the product is officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.

Section 51945-4 (51945-4)

NDC: 43406-0217-1

ARNICA MONTANA 30C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves aches, pains and bruising.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 30C

Advanced Ingredient Data

[{"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "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)

{"34067-9": "USES: Temporarily relieves aches, pains and bruising.**", "34068-7": "DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.", "34071-1": "WARNINGS: Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING , ask as health care professional before use. KEEP OUT OF THE REACH OF CHILDREN . In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. Do not use if TAMPER EVIDENT seal is broken or missing.", "34093-5": "* The letters "HPUS" indicate the component in the product is officially monographed in the Homeopathic Pharmacopeia of the United States. **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.", "50565-1": "KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.", "51727-6": "INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.", "51945-4": "NDC: 43406-0217-1 ARNICA MONTANA 30C HOMEOPATHIC 1 fl oz (30 mL) / 20% Alcohol", "53413-1": " QUESTIONS & COMMENTS? Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600", "55105-1": "USES: Temporarily relieves aches, pains and bruising.**", "55106-9": "ACTIVE INGREDIENT (HPUS*): Arnica Montana 30C"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:07.665418 · Updated: 2026-03-14T23:15:22.245910