Tintuta De Mentiolate/menthiolate Tincture
FDA Label NDC 70242-128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Tintuta De Mentiolate/menthiolate Tincture (NDC 70242-128). 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%) ................... Antiseptic

Otc - Purpose

Use

May help prevent skin infection in

  • minor cuts
  • scrapes 
  • burns

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.

Indications & Usage

Antiseptic

For External Use Only

Dosage & Administration

Directions

  • clean the affected area
  • and dry thoroughly. Apply a thin layer 1 to 3 times daily.
  • May be covered with a sterile bandage, let dry first.

Warnings

Warnings For external use only

Avoid Contact with eyes.

When using this product

Inactive Ingredient

Inactive Ingredients Acetone, FD&C red # 22, Isopropyl Alcohol, Purified Water.

Package Label.Principal Display Panel

Label Image (Tinturamentiolate)

Label Image (Tinturamentiolate)

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