SOOTHE AND COOL- white petrolatum ointment

Soothe and Cool by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

White Petrolatum 93.5%

Purpose

Skin Protectant

Uses

■ Helps treat and prevent diaper rash

■ Protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness

■ Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips

■ Temporarily protects minor cuts, scrapes, and burns

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

• apply as needed
  

Other information

• Protect from freezeing. Avoid excessive heat.

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

REF MSC095094

www.medline.com

Manufactured in USA for Medline Industries, Inc.

Mundelein, IL 60060 USA

1-800-MEDLINE

Package Label

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL 
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	935 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CORN OIL (UNII: 8470G57WFM)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ERGOCALCIFEROL (UNII: VS041H42XC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-067-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2007

Labeler - Medline Industries, Inc. (025460908)