Petrolatum Cream
FDA Label NDC 33992-0498

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Petrolatum (NDC 33992-0498). 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 active ingredient:, purpose, uses, warnings, when using this product,, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

White Petrolatum USP (30 %)

Purpose

Skin protectant

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

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

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), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

110781 DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

MADE IN INDIA

Skin Softener

Hydrates &

Evens Skin Tone

COCOA

BUTTER

Petroleum Jelly

C. No. DNH/COS/DNH/130

1222101976

Principal Display Panel - 3 Oz Tube Label

ASSURED™

Vitamin E Enriched

Creamy

COCOA
BUTTER

Petroleum Jelly

Skin Softener

Hydrates &
Evens Skin Tone

Net Wt 3 oz (85g)

NDC # 33992-0498-1

Principal Display Panel (3 oz Tube Label)

Principal Display Panel (3 oz Tube Label)

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