Menthozen Cream
FDA Label NDC 71574-600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Village Pharma Llc for the product Menthozen (NDC 71574-600). 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 ingredients:, uses:, warnings:, keep out of reach of children., do not apply, if pregnant or breast feeding,, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Methyl Salicylate 20.00%

Menthol 5.00%

Capsaicin 0.0375%

Uses:

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

Warnings:

  • For external use only.
  • Avoid contact with the eyes.
  • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Do Not Apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

If Pregnant Or Breast Feeding,

contact a physician prior to use.

Directions:

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

Other Information:

Store at room temperature.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

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