Arnica Montana 200c

Arnica Montana 200c
SPL v3
SPL
SPL Set ID 636259e7-0f80-4fbf-b1d7-896377f7cee4
Route
ORAL
Published
Effective Date 2022-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (200 [hp_C])
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2001-12-03
Description

ACTIVE INGREDIENT (HPUS*): Arnica Montana 200C

Medication Information

Warnings and Precautions

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF HTE 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 from bruising & sore muscles.**

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 200C

Section 34093-5

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

** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF HTE 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 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4

NDC: 43406-0311-1

ARNICA

MONTANA 200C

 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 from bruising & sore muscles.**

Section 55106-9

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 200C

Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves aches & pains from bruising & sore muscles.**

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 a health care professional before use.
  • KEEP OUT OF HTE 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 this product is officially monographed in the Homeopathic Pharmacopeia of the United States.

** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1 (50565-1)

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF HTE 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 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4 (51945-4)

NDC: 43406-0311-1

ARNICA

MONTANA 200C

 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 from bruising & sore muscles.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 200C

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:07.628715 · Updated: 2026-03-14T23:15:22.245910