FDA Label for Top Medicated Oil

View Indications, Usage & Precautions

Top Medicated Oil Product Label

The following document was submitted to the FDA by the labeler of this product Big 5 Nutrition 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 Ingredients



Camphor 10%

Menthol 16%

Methyl Salicylate 40%


Purpose



External Analgesic


Uses



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

• simple backache • arthritis  • strains • bruises • sprains 


Warnings



For external use only

Do not use

• on wounds

• on irritated or damaged skin

• otherwise than as directed

When using this product

• avoid contact with the eyes or mucous membranes

• do not bandage tightly

Stop use and ask a doctor if

• condition worsens  • symptoms persist for more than 7 days

• symptoms clear up and occur again within a few days

• excessive irritation of the skin develops

• nausea, vomiting, abdominal discomfort, diarrhea, or skin rashes occurs


Directions



• adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations. 

• children under 12 years of age: consult your physician.

• refer to the above warnings; use otherwise than as directed may be dangerous.


Other Information



• store at 16° to 30°C (61° to 86° F) • store in an airtight container


Inactive Ingredients



• Eucalyptus oil • Lavender oil


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