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  5. Label Information: Arnicool

FDA Label for Arnicool

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT IF
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Arnicool Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Resolution Laboratory, 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.

Active Ingredient



Menthol 4%


Purpose



Cooling Pain Relief


Uses



Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.


Warnings



(For external use only)


Do Not Use This Product If



  • Tamper Evident "Do Not Use...Seal..."label atop the container is broken
  • Pregnant or breastfeeding, ask a health professional before use

When Using This Product



  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Do not use with heating pad or device

Stop Use And Ask A Doctor If



Condition worsens, or if symptoms persist for more than 7 days, or clear up and reccur.


Keep Out Of Reach Of Children



In case of accidental overdose or if ingested, contact a doctor or Poison Control Center immediately.


Directions



  • Adults and children 12 years of age older: Apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 times daily for 2 weeks, then as needed.
  • Children under 12 years of age:consult a physician.

Other Information



  • Store in room temperature (59~86°F).

Inactive Ingredients



Water, Arnica Montana Flower Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Centella Asiatica Extract, Glycerin, Xanthan Gum, Glucosamine, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Seed Oil, Dromiceius (Emu) Oil, Pyridoxine Hydrochloride (Vitamin B6), Butyrospermum Parkii (Shea) Butter, Dimethicone, Frankincense Serrata Oil, Lavandula Officinalis (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Tocopherol, Dipotassium Glycyrrhizinate, Glyceryl Stearate / PEG-100 Stearate, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Ethoxydiglycol, Lecithin, Cholesterol, Phenoxyethanol, Disodium EDTA


Package Labeling:



Label3 - Label3

Label3 - Label3


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