Dermaseptin
FDA Label NDC 61924-210

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 Dermaseptin (NDC 61924-210). 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 ingredients, purpose:, uses:, warnings, warnings:, other information:, inactive ingredients:, dermaseptin 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 Ingredients

  • Zinc Oxide 20.65%
  • Menthol 0.50%

Purpose:

  • Zinc Oxide: Skin protectant/Moisure barrier
  • Menthol: External analgesic/First-aid antuseptic/Antipuritic

Uses:

A moisture barrier that prevents and helps treat skin irritations from:

  • urine
  • diarrhea
  • perspiration
  • fistula drainange
  • minor cuts and burns
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • scrapes
  • itching

Warnings

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.

  • Do not use on deep or puncture wounds.

  • Stop use and ask a doctor if condition worsens or does not improve within 7 days

Warnings:

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

Other Information:

Store at room temperature (59°-86°F).

Inactive Ingredients:

Calamine, Glycerin, Lanolin, Methylparaben, Petrolatum, Propylparaben, Sodium Bicarbonate

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