Royal Petroleum (vitamin E Enriched)
FDA Label NDC 50438-401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Royal Petroleum (vitamin E Enriched) (NDC 50438-401). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Creamy petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

*This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline (r)

MADE IN CHINA

DISTRIBUTED BY:
Filo America

P.O. Box 23592

Los Angeles, CA 90023

Questions or Concerns?

1.866.460.0322

Otc - Active Ingredient

DRUG FACTS  

Active Ingredient                                     Purpose

Petrolatum 30%                                      Skin Protectant

Otc - Purpose

Purpose

Skin Protectant

Indications & Usage

Temporarily protects minor: cuts  scrapes  burns

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings

Warnings

For external use only. Do not use on deep puncture wounds.

Otc - When Using

When using this product, do not get into eyes

Otc - Stop Use

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

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.

Dosage & Administration

Directions: apply as needed

Inactive Ingredient

Inactive ingredients:

water (Aqua),  Carbopol 940, Stearic Acid, Glyceryl Monostearate, Mineral Oil, Cetearyl Alcohol, GE125 Emulsifying Agent, Methylparaben, Propyparaben, Triethanolamine, Tocopheryl Acetate, Cocoa Butter, Fragrance.

* Please review the disclaimer below.