Lanoderm
FDA Label NDC 61924-232

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 Lanoderm (NDC 61924-232). 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:, lanoderm 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:

Lanolin USP 30%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve

  • irritation from chafed and abraded skin due to incontinence
  • skin irritations resulting from friction and rubbing

Warnings:

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Do not use on deep or punctured wounds.
  • Stop use and ask doctor if condition worsens or does not improve within 7 days.
    • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

Apply liberally to affected area as needed or as directed by physician.

Other Information:

Store at room temperature (59o- 86oF)

Inactive Ingredients:

Cera Alba, Disodium EDTA, DMDM Hydantion, Lanolin Alcohol, Methylparaben, Mineral Oil, PEG-30 Dipolyhydroxydstearate, Petrolatum, Propylene Glycol, Propylparaben, Sodium Borate, Sodium Chloride, Water

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