Truelipids Truelips Lip Balm Solution
FDA Label NDC 61387-255

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 Truelips Lip Balm (NDC 61387-255). 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, indications & usage, warnings, dosage & administration, inactive ingredient, 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 50% Skin Protectant (ointment)

Otc - Purpose

Uses

  • helps prevent and temporarily protects chafed, chapped,or cracked lips
  • helps prevent and 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.

Warnings

Warnings

For external use only

Dosage & Administration

Directions

  • ​apply as needed day or night

Inactive Ingredient

Inactive Ingredients:

Carpylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-30 Cholesterol/Lanosterol Esters, Glycyrrhetinic Acid(from Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol

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