Inofoam Antibacterial
FDA Label NDC 58575-526

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Inopak, Ltd for the product Inofoam Antibacterial (NDC 58575-526). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, 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

Antiseptic

Indications & Usage

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • recommended for repeated use.

Warnings

Warnings

For external use only.

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.

Dosage & Administration

Directions

  • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
  • Wash both hands thoroughly for 15 seconds.
  • Rince under running water and dry thoroughly.

Inactive Ingredient

Inactive ingredients Water, Laurtrimonium Chloride, Cocamidopropyl Betaine, PEG-6 Cocamide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Iodopropyl Butylcarbamate, Red 4.

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