FDA Label for Methyl Salicylate 25% Cream

View Indications, Usage & Precautions

Methyl Salicylate 25% Cream Product Label

The following document was submitted to the FDA by the labeler of this product Forreal Pharmaceuticals Llc. 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.

Active Ingredient



Methyl Salicylate 25%


Purpose



Topical analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.


Warnings



For external use only.


When Using This Product



  • Avoid contact with the eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • Do not apply to wounds or damaged skin
  • Do not bandage

Stop Use And Ask A Doctor If



  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.



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


Directions



adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask a doctor

Other Information



  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients



Aloe vera leaf, Glycerine, Arnica Montana Flower, Indian Frankincense, Cetostearyl Alcohol, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Monostearate, C13-14 Isoparaffin, Isosteryl Palmitate, Trolamine, Stearic Acid, Propylene Glycol, Laureth-7, Peg-100 Stearate, Water, Phenoxyethanol

Methyl Salicylate 25% Cream

NDC: 81877-721-01

120 grams

Manufactured for:
Forreal Pharmaceuticals, LLC
Royal Oak, MI 48067


Principal Display Panel



NDC: 81877-721-01
Methyl Salicylate 25% Cream
120 grams

Manufactured For:

Forreal Pharmaceuticals, LLC
Royal Oak, MI 48067
Questions or Comments Please call
877-367-3250


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