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  5. Label Information: Arnica Montana 200c

FDA Label for Arnica Montana 200c

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 200c 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 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.