SOOTHE AND COOL INZO BARRIER- dimethicone cream 
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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777 Soothe and Cool INZO Barrier

Active ingredient

Dimethicone 5%

Purpose

Skin Protectant

Uses

Temporarily protects

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

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

Soothe&Cool INZO Barrier Cream

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)

SOOTHE AND COOL INZO BARRIER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-777-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/01/200912/31/2017
2NDC:53329-777-96144 in 1 BOX04/01/200912/31/2017
28 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2009
Labeler - Medline Industries, LP (025460908)

Revised: 11/2021
Document Id: d103ac3e-c8da-4546-e053-2995a90aa0f5
Set id: 9e6bfd97-dcbe-4f3d-8a2e-b2b7af66fae3
Version: 10
Effective Time: 20211117
 
Medline Industries, LP