FDA Label for 2.5% Menthol Pain Relief

View Indications, Usage & Precautions

2.5% Menthol Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center 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.

Drug Facts




Active Ingredient (In Each Gram)



Menthol 2.5%


Purpose



Topical analgesic


Uses



• temporarily relieves the 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 skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When using this product
• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs


Otc - Keep Out Of Reach Of Children



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


Directions



• 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: ask a doctor


Other Information



• store at 20° to 25°C (68° to 77°F)


Inactive Ingredients



Cinnamomum camphora(camphor) bark oil, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Methylparaben, Polysorbate 20, Propylparaben, Purified Water, Sodium Hydroxide.


Packaging




* Please review the disclaimer below.