SOOTHE AND COOL PROTECT- zinc oxide and white petrolatum paste 
Medline Industries, Inc.

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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Drug Facts

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

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

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

www.medline.com

Manufactured in USA for Medline Industries, Inc.,

Mundelein, IL 60060 USA.
1-800-MEDLINE

NDC: 53329-004-10

SOOTHE & COOL®

PROTECT

ZINC OXIDE

SKIN PASTE

Net Wt. 2.5 oz (71 g)

REF MSC095450

label

SOOTHE AND COOL PROTECT 
zinc oxide and white petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-004-0271 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 finalpart34601/01/2007
Labeler - Medline Industries, Inc. (025460908)
Registrant - Dhaliwal Labs Illinois, Llc (079679410)

Revised: 1/2019
Document Id: 7f3ac9ed-595e-f82e-e053-2a91aa0a8699
Set id: 2bd6e71d-5549-7110-e054-00144ff8d46c
Version: 7
Effective Time: 20190111
 
Medline Industries, Inc.