Dermakleen
FDA Label NDC 61924-092

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 Dermakleen (NDC 61924-092). 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:, inactive ingredients:, questions?, dermakleen 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

Active Ingredient:

Chloroxylenol 0.2%

Purpose:

Antimicrobial

Uses:

For handwashing to decrease bacteria on the skin.

Warnings

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if irritation or redness develops.

    • Keep out of children's reach except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center rightaway.

Directions:

  • Dispense into hands, wet as needed.
  • Lather vigorously for at least 15 seconds
  • Wash skin, rinse thoroughly and dry.

Inactive Ingredients:

Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.

Questions?

Call 1-800-337-6296

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