Top Medicated
FDA Label NDC 50943-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A&a Medical Supplies for the product Top Medicated (NDC 50943-001). 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 top medicated oil, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Top Medicated Oil


Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Purpose

External Analgesic

Uses

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

  • simple backache
  • strains
  • bruises
  • arthritis
  • sprains


Warnings

For external use only

Otc - Do Not Use


Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed

Otc - When Using

When using this product

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

Otc - Stop Use

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 rash 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 right away.

Directions

  • adults and children 3 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 massaged as shown in the illustrations.
  • children under 3 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 degrees C (16 to 86 degrees F)
  • preserve in tight container

Inactive Ingredients

  • Clove Oil
  • Lavender Oil
  • Turpentine Oil

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