Zensezone Arthmed Temporary Pain Relief Cream
FDA Label NDC 82319-240

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zensezone Llc for the product Zensezone Arthmed Temporary Pain Relief Cream (NDC 82319-240). 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 drug facts, active ingredients:, purpose:, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

Capsaicin 0.025%

Menthol 10%

Methyl Salicylate 15%

Purpose:

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.

Warnings:

For external use only not intended for ingestion.

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. Rinse with water to remove 
  • Do not bandage tightly.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur agin within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • Adults and children two-years of age an older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate') Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Other Information:

  • Potect the product in this container from excessive heat and direct sun.

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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