SOOTHE AND COOL INZO BARRIER- dimethicone cream

Soothe and Cool INZO Barrier by

Drug Labeling and Warnings

Soothe and Cool INZO 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

Dimethicone 5%

Purpose

Skin Protectant

Uses

Temporarily protects

• and helps relieve chapped or cracked skin
• 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 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

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

Inactive ingredients

Benzethonium Chloride, Cetyl Alcohol, Chloroxylenol, Cholecalciferol, Glyceryl Stearate, Lanolin, Quaternium-15, Retinyl Palmitate, Sodium Cocoyl Isethionate, Sorbitol, Tocopheryl Acetate, Water, Zinc Oxide.

Package/Label Principal Display Panel

NDC: 53329-777-04

Soothe & Cool

Protect

INZO Barrier Cream

with 5% dimethicone

Invisible Skin Protectant

Contains Zinc Oxide

Extra-Strength

REF MSC095420

Medline

4 Fl. Oz. (118.29 mL)

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL INZO BARRIER 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
QUATERNIUM-15 (UNII: E40U03LEM0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SORBITOL (UNII: 506T60A25R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-777-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2009	12/31/2017
2	NDC: 53329-777-96	144 in 1 BOX	04/01/2009	12/31/2017
2		8 mL 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	04/01/2009

Labeler - Medline Industries, Inc. (025460908)