Arnica Montana 200c Liquid
FDA Label NDC 43406-0311

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Arnica Montana 200c (NDC 43406-0311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT (HPUS*):

Arnica Montana 200C

Otc - Purpose

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

Indications & Usage

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

Dosage & Administration

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

Otc - Keep Out Of Reach Of Children

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.

Warnings

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.

Inactive Ingredient

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?

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

References

* 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.

Package Label.Principal Display Panel

NDC: 43406-0311-1

ARNICA

MONTANA 200C

 HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

* Please review the disclaimer below.