Antimicrobial Foam
FDA Label NDC 54057-305

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afflink, Inc. for the product Antimicrobial Foam (NDC 54057-305). 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 antimicrobial foam, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Antimicrobial Foam

​Active Ingredient

​ ​Triclosan 0.30%

Uses

  • ​​Antibacterial hand cleaner.
  • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

    • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.

      • Directions

      • ​Read the entire label before using this product.
      • ​Dispense 0.8 mL of product onto wet palm.
      • Rub hands together to distribute product, then rinse hands with clean.

        • Inactive Ingredients

        ​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

        Purpose

        ​Antibacterial

        KEEP OUT OF REACH OF CHILDREN

        AFFEX CLEANING SOLUTIONS

        Antimicrobial Foam Soap

        Foaming Skin Cleanser with Triclosan

        MEDICAL EMERGENCY:

        (800)424-9300

        NET CONTENTS: 1000 mL

        ITEM #305-60

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