Arnicool
FDA Label NDC 63742-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Resolution Laboratory, Inc. for the product Arnicool (NDC 63742-007). 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 active ingredient, purpose, uses, warnings, do not use this product if, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Label4 (Label4)

Label4 (Label4)

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