Otc - Active Ingredient
White Petrolatum USP (93.4% w/w)
Claravie Ointment
FDA Label NDC 61554-304
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-304). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, inactive ingredient, dosage & administration, warnings, indications & usage, 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 - Purpose
Skin Protectant
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek profesional assistance or contact a Poison control Center immediately
Inactive Ingredient
Lanolin, Light Mineral Oil, Paraffin, Vitamin A, Vitamin D, Vitamin E and Cl 12740
Dosage & Administration
Apply as needed
Warnings
For external use only. When using this product do not get into eyes
Indications & Usage
- Temporarily protects minor cuts, scrapes, burns.
- Temporarily protects and helps relieve chapped or cracked skin and lips
- Heps protect aganist the drying effects of wind and cold weather
* Please review the disclaimer below.
