Menthol Pain Relieving Cream With Menthol 10% Cream
FDA Label NDC 55629-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Menthol Pain Relieving Cream With Menthol 10% (NDC 55629-018). 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 ingredient:, purpose, uses:, warnings:, when using this product,, directions:, 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

Drug Facts:

Active Ingredient:

Menthol 10%

Purpose

  • Pain relieving cream

Uses:

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple 
  • backache 
  • arthritis 
  • strains
  • bruises 
  • sprains

Warnings:

  • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

When Using This Product,

  • use only as directed 
  • avoid contact with the eyes or on mucous membranes 
  • do not apply to wounds or damaged skin 
  • do not apply to irritated skin or if excessive irritation develops 
  • do not bandage tightly or use with heating pad or device

Directions:

  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily 
  • children under 12 years of age: consult a physician 
  • wash hands after use with cool water

    • Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Other Information:

store at 20-25°C (68-77°F)  store in a cool dry place away from direct sunlight

Package Label

Jar5ozabel (Jar5ozabel)

Jar5ozabel (Jar5ozabel)

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