SOOTHE AND COOL- 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.

----------

067 Soothe and Cool Protect A&D

Active ingredient

White Petrolatum 93.5% 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
  • symptoms last for more than 7 days or 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

Other information

Inactive ingredients

Corn Oil, Light Mineral Oil, Retinyl Palmitate (Vitamin A Palmitate), Ergocalciferol (Vitamin D)

Manufacturing Information

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE

REF: MSC095094

RD19ULI

Package Label

label 067

SOOTHE AND COOL 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM935 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ERGOCALCIFEROL (UNII: VS041H42XC)  
CORN OIL (UNII: 8470G57WFM)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-067-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01601/01/2007
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efceb3a5-8762-fb96-e053-2995a90a1c8f
Set id: 405163d3-c61d-4481-999a-b17ec33589d6
Version: 6
Effective Time: 20221214
 
Medline Industries, LP