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  5. Label Information: Arnica Gel

FDA Label for Arnica Gel

View Indications, Usage & Precautions

Table of Contents

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

Arnica Gel Product Label

The following document was submitted to the FDA by the labeler of this product King Bio 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



Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana 1X HPUS*-7%

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.


Indications & Usage



Uses Temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.


Warnings



Warnings:

  • For external use only. Avoid contact with eyes and broken skin.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Nursing mothers should not apply to breast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Stop use and ask a doctor if: •symptoms worsen or do not improve within 3 days •skin irritation, redness or rash occurs.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children.

Dosage & Administration



Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply at the onset of symptoms.


Other Safety Information



Other information:

  • Do not use if carton or tube seal is broken.
  • Store at 68-77°F (20-25°C).
  • Keep carton for complete drug facts and product information.

Inactive Ingredient



Inactive ingredients:  Alcohol denat, carbomer, purified water, sodium hydroxide.


Otc - Purpose



Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose†

Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion.

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.


* Please review the disclaimer below.