SOOTHE AND COOL FREE MOISTURE BARRIER- petrolatum ointment

Soothe and Cool Free Moisture Barrier by

Drug Labeling and Warnings

Soothe and Cool Free 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

Petrolatum 92.8%

Purpose

Skin Protectant

Uses

Temporarily protects minor:

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

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 consult a Poison Control Center right away.

Directions

• cleanse skin
• apply ointment as needed

Other Information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice (Aloe Vera), Benzethonium Chloride, Cholecalciferol (Vitamin D 3), Isopropyl Myristate, Octyl Hydroxystearate, Propylene Glycol, Retinyl Palmitate (Vitamin A)

Package Label - packet

Package Label - box

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL FREE MOISTURE BARRIER 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	92.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-072-96	144 in 1 CARTON	01/01/2007
1	NDC: 53329-072-16	5 g in 1 PACKET; Type 0: Not a Combination Product

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)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(53329-072)