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NDC 53329-0776-04 Soothe and Cool Inzo 5 g/100mL Details

Soothe and Cool Inzo 5 g/100mL

Soothe and Cool Inzo is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is DIMETHICONE.

Product Information

NDC	53329-0776
Product ID	53329-776_cf2ebdbb-6134-6fcc-e053-2a95a90a194d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Soothe and Cool Inzo
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100mL
Substance Name	DIMETHICONE
Labeler Name	Medline Industries, LP
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 53329-0776-04 (53329077604)

Pricing Information	N/A
NDC Package Code	53329-776-04
Billing NDC	53329077604
Package	118 mL in 1 TUBE (53329-776-04)
Marketing Start Date	2016-01-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2bd1149a-5687-6e11-e054-00144ff8d46c Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-776-96	144 in 1 CARTON	01/21/2016	05/30/2023
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	05/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/21/2016	05/30/2023

Labeler - Medline Industries, LP (025460908)

Revised: 10/2021

Document Id: cf2ebdbb-6134-6fcc-e053-2a95a90a194d

Set id: 2bd1149a-5687-6e11-e054-00144ff8d46c

Version: 5

Effective Time: 20211025