Truelipids Relieve And Protect Ointment
FDA Label NDC 61387-254

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Claridei Laboratories, Inc. for the product Truelipids Relieve And Protect (NDC 61387-254). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredients, 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

Otc - Active Ingredient

Active Ingredient Purpose

White Petrolatum, USP (50%) Skin Protectant

Otc - Purpose

Uses

  • helps relieve, prevent and temporarily protects chafed, chapped, cracked or windburned skin and lips
  • temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • helps protect from the drying effects of wind and cold weather

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Warnings

For external use only

When using this product

  • avoid contact with eyes

    • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

Directions

  • ​apply generously to affected areas as needed. For best results, use right after a shower or bath

Inactive Ingredients

Caprylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-C30 Cholesterol/Lanosterol Esters, Glycyrrhetinic Acid (from Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol.

Package Label.Principal Display Panel

CLMD

Sensitive Skin Care

Truelipids

Relieve & Protect Ointment

Net Wt 3.5 oz (100g)

* Please review the disclaimer below.