Active Ingredient:
Petrolatum 33%
Dermacerin
FDA Label NDC 61924-174
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 Dermacerin (NDC 61924-174). 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:, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Skin Protectant
Uses:
- Temporarily protects and helps relieve dry, chapped, or cracked skin.
- Helps protect skin from the drying effects of wind and cold weather.
Warnings:
For external use only.
Avoid contact with eyes. In case of contact, flush thoroughly with water
Stop and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days.
Do not use on deep or puncture wounds, animal bites, or serious wounds.
Keep out of reach of children.
In case of accidental ingestion contact a Physician or Poison Control Center right away.
Directions:
Apply as needed or as directed by a physician.
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, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride
Questions?
Call 800-337-6296 Mon - Fri 9AM - 5PM EST.
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