Lantiseptic By Dermarite Original Skin Protectant
FDA Label NDC 61924-304

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 Lantiseptic By Dermarite Original Skin Protectant (NDC 61924-304). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

  • Helps relieve and prevent rashes and irritation due to wetness from incontinence.
  • Protects chafed skin due to irritation and helps seal out wetness.

Warnings

For external use only.

Avoid contact with eyes.

In case of contact, flush thoroughly with water.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Directions

  • Cleanse and remove any urine or fecal matter from area; pat dry.
  • Apply generously to affected area as neeeded, especially after incontinence episodes.
  • Repeat after each incontinent episode or as needed.

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

Cera Alba, DMDM Hydantoin, Disodium EDTA, Lanolin Alcohol, Mineral Oil, Petrolatum, Sodium borate, Sorbitan Sesquioleate, Water

Questions Or Comments?

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