Merthiolate
FDA Label NDC 10095-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by World Perfumes, Inc for the product Merthiolate (NDC 10095-005). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                            Purpose

Benzalkonium Chloride 0.13%          First Aid Antiseptic

Otc - Purpose

Use first aid to help prevent skin infection in 

  • minor cuts
  • scrapes
  • burns

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Merthiolate Tincture

Mercury Free

First Aid Antiseptic

For External Use Only

Dosage & Administration

Directions

  • clean the affected area
  • apply a small amount on the area 1 to 3 times daily
  • may be covered by a sterile bandage
  • if bandaged, let dry first

Warnings

Warnings

  • For external use only
  • Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
  • When using this product
  • do not use in eyes or apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor if condition persists or gets worse

Inactive Ingredient

Inactive Ingredients alcohol, acetone, purified water, FD&C red #22

* Please review the disclaimer below.