Top Medicated Oil
Top Medicated Oil is an FDA drug label for the active ingredient CAMPHOR, MENTHOL, METHYL SALICYLATE manufactured by Big 5 Nutrition LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231121.
- Generic name
- CAMPHOR, MENTHOL, METHYL SALICYLATE
- Manufacturer
- Big 5 Nutrition LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 82198-0009
- Application
- M017
- Label effective
- 20231121
Active ingredients
Indications & Usage
Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • bruises • sprains
Dosage & Administration
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.
Contraindications
Not available.
Warnings
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
Adverse Reactions
Not available.