SOOTHE AND COOL INZO- dimethicone cream

Soothe and Cool Inzo by

Drug Labeling and Warnings

Soothe and Cool Inzo 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

■ Helps treat and prevent diaper rash caused from wetness, urine and/or stool

■ Temporarily protects and helps relieve chapped or cracked skin

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 dry affected area
• apply liberally to affected area as needed

Inactive ingredients

Benzethonium Chloride, Cetyl Alcohol, Ergocalciferol, Glycerol Monostearate, Lanolin, PCMX Surcide, Quaternium-15, Sodium Lauryl Sulfate, Sorbitol, Vitamin A Palmitiate, Vitamin E Acetate, Water, Zinc Oxide

SPL UNCLASSIFIED SECTION

REF MSC095422

www.medline.com
Manufactured in USA with
domestic and imported materials
for Medline Industries, Inc.,
Mundelein, IL 60060 USA.
1-800-MEDLINE

PRINCIPAL DISPLAY PANEL

SOOTHE & COOL®

Protect

INZO® BARRIER CREAM

• Invisible Skin Protectant
• 5% Dimethicone
• Zinc Oxide

.24 FL OZ (7 mL)

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL INZO 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-776
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)
ERGOCALCIFEROL (UNII: VS041H42XC)
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
QUATERNIUM-15 (UNII: E40U03LEM0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-776-96	144 in 1 CARTON	01/21/2016
1		7 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 53329-776-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/21/2016

Labeler - Medline Industries, Inc. (025460908)