Top Medicated Oil
FDA Label NDC 82198-0009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Big 5 Nutrition Llc for the product Top Medicated Oil (NDC 82198-0009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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