Monk
FDA Label NDC 50320-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by National Towelette Company for the product Monk (NDC 50320-111). 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 principal display panel, otc - active ingredient, otc - purpose, dosage & administration, 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

Principal Display Panel

MM1

Label (Untitled)

Label (Untitled)



Otc - Active Ingredient

Active Ingredients:Benzethonium Chloride (0.3%)

Otc - Purpose

Purpose:

Antibacterial

Dosage & Administration

Use decreases bacteria on skin

Directions: Adults and children 2 years and over: apply on hands and face to clean and refresh. Allow skin to dry without wiping. Children under 2 years: as a doctor before use. For Children under 6 use only under supervision.

Warnings

Warnings For external use only

Otc - Do Not Use

Do not use
  • over large areas
  • If you are allergic to any of the ingredients

Otc - When Using

When using this product

  • do not get into eyes
    • If contact occurs, rinse thoroughly with water

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Otc - Keep Out Of Reach Of Children

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

Inactive Ingredient

Inactive Ingredients: Water, SD Alcohol 40-B, Sodium Benzoate, Diazolidinyl Urea, Glycerin, Propylene Glycol, Potassium Sorbate, Disodium EDTA, Tocopheryl Acetate, Aloe

Storage And Handling

Store under 110 F

Otc - Questions

Questions and Comments: For products or technical information, contact National Towelette Monday to Friday 8 AM to 4 PM EST at 1-800-738-9068, or visit our website at www.towelettes.com

* Please review the disclaimer below.