Kleenfoam
FDA Label NDC 61924-093

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries Llc for the product Kleenfoam (NDC 61924-093). 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 active ingredient, purpose:, uses:, warnings:, directions:, other information:, inactive ingredients:, question?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Chloroxylenol 0.5%

Purpose:

Antiseptic Handwash

Uses:

  • For handwashing to decrease bacteria on the skin.
  • after changing diapers;
  • after assisting ill persons;
  • before contact with a person under medical care or treatmentRecommended for repeated use.

Warnings:

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns
  • When using this product, do not apply to areas of raw or blistered skin in large quantities, do not use in or near the eyes
  • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days or clear up and recur within a few days

    • For external use only.

    Avoid contact with eyes. In case of contact, flush thoroughly with water.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:

  • Wet hands and forearms.
  • Apply 5 millimeters (teaspoon) or palmful to hands and forearms.
  • Scrub thoroughly for 15 seconds.
  • Rinse and repeat.

Other Information:

Store at room temperature (59°-86°F). You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Polysorbate 20, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Disodium EDTA, Sodium Isostearoyl lactylate, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide

Question?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

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