SOOTHE AND COOL PROTECT- zinc oxide and white petrolatum paste

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, Inc., Dhaliwal Labs Illinois, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

White Petrolatum 50%

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

■ Temporarily relieves skin irritation including itching, burning, and discomfort

■ Temporarily forms a protective coating over inflamed tissues to help prevent drying

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

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 the eyes

Stop use and ask a doctor if

• Condition worsens or does not improve within 7 days

Keep out of reach of children

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

Directions

• gently cleanse and dry affected area
• apply liberally to affected area as needed
  

Other information

Protect from freezing, avoid excessive heat.

Inactive ingredients

Allantoin, Benzethonium Chloride, Eugenia Caryophyllus (Clove) Flower Oil, Zea Mays (Corn) Starch, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Xanthan Gum

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in USA for Medline Industries, Inc.,

Mundelein, IL 60060 USA.
1-800-MEDLINE

PRINCIPAL DISPLAY PANEL

NDC: 53329-004-10

SOOTHE & COOL®

PROTECT

ZINC OXIDE

SKIN PASTE

• Provides a thick, protective barrier
• Enhanced with vitamins A & E

Net Wt. 2.5 oz (71 g)

REF MSC095450

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL PROTECT 
zinc oxide and white petrolatum paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CLOVE OIL (UNII: 578389D6D0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STARCH, CORN (UNII: O8232NY3SJ)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-004-02	71 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	part346	01/01/2007

Labeler - Medline Industries, Inc. (025460908)

Registrant - Dhaliwal Labs Illinois, Llc (079679410)