FDA Label for Methyl Salicylate

View Indications, Usage & Precautions

Methyl Salicylate Product Label

The following document was submitted to the FDA by the labeler of this product Alaina Healthcare Private Limited. 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                                               Purpose



Methyl Salicylate 25%........................................Topical Analgesic


Uses



Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • lumbago
  • arthritis
  • neuralgia
  • strains
  • bruises
  • sprains

Warnings



For external use only.


When Using This Product



  • avoid contact with the eyes
  • do not use in larger quantities, particularly over raw surfaces or blistered areas
  • do not apply to wounds or damaged skin
  • do not bandage

Stop Use And Ask 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.


Other Information



May be applied under occlusive dressing

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.


Inactive Ingredients



C13-14 isoparaffin, cetearyl alcohol, chondrotin sulfate sodium, Ethylhexylglycerin, glucosamide sulfate potassium chloride, glycerin, glyceryl stearate, isostearic acid, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, water


Principal Display Panel



Methyl Salicylate Cream 25% - NDC 73492-273-60 - 2.11 OZ (60g) Tube Label

Methyl Salicylate Cream 25% - NDC 73492-273-60 - 2.11 OZ (60g) Carton Label


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