Antibacterial Foaming Skin Cleanser Soap
FDA Label NDC 65601-709

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Betco Corporation, Ltd. for the product Antibacterial Foaming Skin Cleanser (NDC 65601-709). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - purpose, otc - keep out of reach of children, 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%

Indications & Usage

Uses

  • ​​Antibacterial skin cleanser.
  • Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

Warnings

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

Inactive Ingredient

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

Otc - Purpose

Purpose

Antibacterial

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

* Please review the disclaimer below.