The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Royal Petroleum (cocoa Scent) (NDC 50438-400). 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.
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
DRUG FACTS
Active Ingredient Purpose
Petrolatum 30% Skin Protectant
Purpose
Skin Protectant
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
For external use only. Do not use on deep puncture wounds.
When using this product, do not get into eyes
Stop use and ask doctor if condition worsens, Symptoms last more than 7 days clear up and occur again within a few days.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions: apply as needed
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.
