WHITE PETROLATUM- white 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.

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White Petrolatum USP Ointment

Drug Facts

Active Ingredients

White Petrolatum USP 100%

Purpose

Skin Protectant

Uses

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

28g label

WHITE PETROLATUM 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-597
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.001 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-597-2828 g in 1 TUBE; Type 0: Not a Combination Product09/27/2018
2NDC:54162-597-055 g in 1 POUCH; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/31/2015
Labeler - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248manufacture(54162-597)

Revised: 10/2018
Document Id: dff5f8e4-a173-4ea3-abb0-a025fb30b9a4
Set id: 9d2dbef6-f7cf-46ed-b991-d66f6412e2e7
Version: 9
Effective Time: 20181012
 
GERITREX LLC