SOOTHE AND COOL MOISTURE BARRIER- petrolatum ointment

Soothe and Cool Moisture Barrier by

Drug Labeling and Warnings

Soothe and Cool Moisture Barrier 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 98.3%

Purpose

Skin Protectant

Uses

• temporarily protects minor: cuts, scrapes, burns
• temporarily protects and helps relieve chapped or cracked skin
• helps treat and prevent diaper rash caused by wetness, urine, and/or stool

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 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 pat dry affected area
• Apply as needed

Inactive ingredients

aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate /caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E).

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured for Medline Industries, Inc.,

Mundelein, IL 60060 USA.

1-800-MEDLINE

PRINCIPAL DISPLAY PANEL

NDC: 53329-071-15

SOOTHE & COOL®

PROTECT

MOISURE BARRIER OINTMENT

Vitamins A, D, & E plus Aloe

Prevents skin breakdown caused by prolonged exposure to moisture

Net Wt. 7 oz (198 g)

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL MOISTURE BARRIER 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	98.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-071-14	56 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2019
2	NDC: 53329-071-15	198 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2006

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(53329-071)