Petrolatum Cream
FDA Label NDC 33992-0499

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 33992-0499). 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, otc - when using, 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.

Otc - When Using

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

Principal Display Panel - Petroleum Jelly Tube Label

ASSURED™

Vitamin E Enriched

Creamy
PETROLEUM
JELLY

Skin Softener

For Dry Skin

Absorbs Quickly

Compare to active ingredient of
Vaseline® Deep Moisture™

Net Wt 3 oz (85g)

NDC # 33992-0499-1

Principal Display Panel (Petroleum Jelly Tube Label)

Principal Display Panel (Petroleum Jelly Tube Label)

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