Xtracare Creamy Petroleum Jelly Cream
FDA Label NDC 57337-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Creamy Petroleum Jelly (NDC 57337-039). 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, other safety information, 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

Petrolatum 30% ........................ Skin Protectant

Otc - Purpose

XtraCare Creamy Petroleum Jelly

Cocoa Butter enriched

Skin Protector

Dry Skin Relief Rich Creamy Moisturizer

*Compare to the active ingredient in Vaseline ® Petroleum Jelly Cream

Net Wt 7oz (198g)

XtraCare®

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

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.

Indications & Usage

Uses

  • 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

When using this product do not get into eyes.

Stop use and ask a doctor if 

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

    • Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

Dosage & Administration

Directions apply as needed.

Inactive Ingredient

Inactive ingredients: water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, fd&c yellow no.5, d&c red no.33

Other Safety Information

Other Information store at room temperature.

Questions/Comments? 1-855-345-5575

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

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

* Please review the disclaimer below.