SOOTHE AND COOL PROTECT- petrolatum jelly

Soothe and Cool Protect by

Drug Labeling and Warnings

Soothe and Cool Protect by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram)

White Petrolatum 100%

Purpose

Skin protectant

Uses

• temporarily protects minor
• cuts
• scrapes
• burns
• temporarily protects and helps relieve chapped or cracked skin and lips
• helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Stop use and ask a doctor if

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

When using this produc

• do not get into eyes

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN.

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

Directions

• apply as needed

Other information

• stor at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF)
• avoid excessive heat and humidity

SPL UNCLASSIFIED SECTION

www.medline.com
Manufactured for: Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of domestic and imported materials. 1-800-MEDLINE RE19ULI

Package Label

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL PROTECT 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-993-04	113 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2019

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(53329-993)