White Petrolatum: Package Insert and Label Information

WHITE PETROLATUM- petrolatum ointment
GERITREX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients

White Petrolatum USP 100%

Purpose

Skin Protectant

Uses

  • Temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • Temporarily protects and helps chapped lips and cracked skin

Warnings

FOR EXTERNAL USE ONLY

Stop use and ask a doctor if:

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

When using this product: avoid contact with eyes

Don’t not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

In case of deep puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or infection occurs, discontinue use and consult a physician.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse area with mild soap and water. Apply White Petrolatum liberally.

Other information

  • Avoid excessive heat and humidity
  • Store at 15-30°C (59-86°F)

28g label
(click image for full-size original)

WHITE PETROLATUM
white petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-597
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL 0.001 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54162-597-28 28 g in 1 TUBE None
2 NDC:54162-597-05 5 g in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 07/31/2015
Labeler — GERITREX LLC (112796248)
Establishment
Name Address ID/FEI Operations
GERITREX LLC 112796248 manufacture (54162-597)

Revised: 10/2018 GERITREX LLC

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