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  5. Label Information: Arnica Montana 30c

FDA Label for Arnica Montana 30c

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Montana 30c Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



​ACTIVE INGREDIENT (HPUS*):

Arnica Montana 30C


Otc - Purpose



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


Indications & Usage



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


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



​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.


Warnings



​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.


Inactive Ingredient



​INACTIVE INGREDIENTS: ​Purified Water, Ethyl Alcohol USP.


Otc - Questions



​QUESTIONS & COMMENTS?

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


References



*​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.


Package Label.Principal Display Panel



​NDC: 43406-0217-1

ARNICA MONTANA 30C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol


* Please review the disclaimer below.