FDA Label for Flexilon

View Indications, Usage & Precautions

Flexilon Product Label

The following document was submitted to the FDA by the labeler of this product Semprae Laboratories Inc. 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



Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%


Purpose



Topical analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only


Do Not Use



  • on wounds or damaged , broken or irritated skin 
  • with a heating pad

When Using This Product



  • avoid contact with eyes or mucous membranes 
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • condition worsens 
  • you have redness over the affected area 
  • symptoms persist for more than 7 days or symptoms clear up and occur within a few days 
  • excessive skin irritation occurs

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Center immediately


Directions



  • use only as directed 
  • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a doctor.

Other Information



store at 20-25C (68-77F)

Do not purchase if outer seal is broken


Inactive Ingredients



carbomer, cetearyl alcohol, D.I. water, FD&C Blue no. 1, FD&C Yellow no.5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine


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