Perigiene
FDA Label NDC 61924-198

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 Perigiene (NDC 61924-198). 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.

Active Ingredient

Chloroxylenol 0.5%

Purpose:

Antiseptic

Uses:

  • Antiseptic cleanser for use in the perineal area.

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

Directions:

  • Apply to perineal area.
  • Wipe with soft cloth.
  • Repeat as needed to clean the area.

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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