SOOTHE AND COOL MOISTURE BARRIER- 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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071 Soothe & Cool Moisture Barrier Ointment

Active ingredient

White Petrolatum 98.3%

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

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

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC095380

V1 RK21UPK

Package Label

Label V1 RK21UPK

SOOTHE AND COOL MOISTURE BARRIER 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM98.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALOE (UNII: V5VD430YW9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-071-1456 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
2NDC:53329-071-15198 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
3NDC:53329-071-96144 in 1 BOX03/01/2006
3NDC:53329-071-165 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:53329-071-165 g in 1 PACKET; Type 0: Not a Combination Product03/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01603/01/2006
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 026dc53f-3b0c-a372-e063-6394a90ac408
Set id: 59625382-2769-4c91-9c53-e19dfd6ca115
Version: 8
Effective Time: 20230808
 
Medline Industries, LP