Antibacterial Hand Cleanser Soap
FDA Label NDC 50865-215

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kutol Products Company for the product Antibacterial Hand Cleanser (NDC 50865-215). 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 Ingredient

Benzalkonium Chloride 0.13% w/w

Otc - Purpose

Purpose

Antibacterial Handwashing

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

Uses Handwash to decrease bacteria on the skin.

Dosage & Administration

Directions

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under 6 years of age should be supervised when using this product.

Warnings

Warnings

For external use only.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if redness and irritation appears and lasts.

Inactive Ingredient

Inactive Ingredients

water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

Package Label.Principal Display Panel

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