Soothe and Cool INZO Barrier

Dosage form: cream
Ingredients: DIMETHICONE 5g in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-777

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.

Drug Facts

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)

SOOTHE AND COOL INZO BARRIER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-777
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE 
CETYL ALCOHOL 
CHLOROXYLENOL 
CHOLECALCIFEROL 
GLYCERYL MONOSTEARATE 
LANOLIN 
QUATERNIUM-15 
VITAMIN A PALMITATE 
SORBITOL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:53329-777-04118 mL in 1 TUBE
2NDC:53329-777-96144 PACKET in 1 BOX
28 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2009
Labeler - Medline Industries, Inc. (025460908)

Revised: 03/2012
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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