MEDLINE- white petrolatum ointment 
Medline Industries, LP

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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146 Remedy Essentials Barrier Ointment

Active ingredient

White petrolatum 98.3% w/w

Purpose

Skin protectant

Uses

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days, or clears up and occurs 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

Other information

Inactive ingredients

aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate/caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E)

Manufacturing information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC095380

V3 Rj22UPK

Package Label

Tube V3 RJ22UPK

MEDLINE 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-146
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM983 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-146-1457 g in 1 TUBE; Type 0: Not a Combination Product03/01/2023
2NDC:53329-146-15198 g in 1 TUBE; Type 0: Not a Combination Product06/01/2023
3NDC:53329-146-1699 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
4NDC:53329-146-8199 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01603/01/2023
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 03110b38-0c57-17d6-e063-6394a90a7d86
Set id: 0075774d-9b20-7e25-e063-6394a90a0fc1
Version: 2
Effective Time: 20230816
 
Medline Industries, LP