FDA Label for Menthol Pain Relieving Cream With Menthol 10%

View Indications, Usage & Precautions

Menthol Pain Relieving Cream With Menthol 10% Product Label

The following document was submitted to the FDA by the labeler of this product One2zee Limited Liability Company. 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.

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




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