FDA.reportPublic FDA data

ChafeZone

Manufacturer
Medzone Products LLC | Dhaliwal Laboratories LLC
Effective date
2021-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:46:09

Label at a glance#

ProductChafeZone
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Dosage and administration

Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing.

Storage and handling

Store at room temperature. Avoid excessive heat.

Label contents#

Full prescribing information#

DRUG FACTS Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Dimethicone 1%Skin Protectant

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Warnings

WARNINGS SECTION

For external use only.

When using this product:

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a physician if:

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on:

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • serious burns
  • animal bites

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Beeswax, Benzoic Acid, BHT, Bisabolol, Butylene/ethylene/styrene Copolymer, Caprylic Capric Triglyceride, C18-36 Acid Triglyceride, ethylene/propylene/styrene copolymer, ethylhexylglycerin, eucalyptus oil, ginkgo biloba leaf extract, glycereth-2 cocoate, glycerin, tea tree leaf oil, peppermint oil, Menthyl lactate, mineral oil, petrolatum, phenoxyethanol, tocopheryl acetate, tribehenin.

Other Information:

STORAGE AND HANDLING SECTION

Store at room temperature. Avoid excessive heat.

Questions?

OTC - QUESTIONS SECTION

Toll-Free 866-MEDZONE ( 866-633-9663)

www.medzonecorp.com info@medzonecorp.com

Distributed by

HOW SUPPLIED SECTION

MedZone Products, LLC

Lenexa, Kansas 66215

All Rights Reserved

principal display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back deoback deofront deofront deo

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-631-002023-01-30C16284748780-1f386c649-fa46-0266-e053-dadaa90a7c1aChafeZone
70338-631-702023-01-30C16284748780-1f386c649-fa46-0266-e053-dadaa90a7c1aChafeZone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-631-00ChafeZone23 g in 1 PACKETSTICK236
70338-631-70ChafeZone43 g in 1 APPLICATORSTICK436

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-631CHAFEZONE (SKIN PROTECTANT) STICK [MEDZONE PRODUCTS LLC]6Legacy NDC, 2 package rows20220101_26a2ba34-eb41-614d-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70338-63170338-631-70, 70338-631-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
C18-36 ACID TRIGLYCERIDEZRA72DR3R7IACT
EUCALYPTUS OIL2R04ONI662IACT
GINKGO19FUJ2C58TIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENEAUG1H506LYIACT
STYRENE44LJ2U959VIACT
TRIBEHENIN8OC9U7TQZ0IACT
YELLOW WAX2ZA36H0S2VIACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
DIMETHICONE92RU3N3Y1OACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
1-BUTENELY001N554LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d477f37d-3d06-39c8-e053-2995a90ab7dd26a2ba34-eb41-614d-e054-00144ff88e882021-12-31WarningsExact identifier
spl id: d477f37d-3d06-39c8-e053-2995a90ab7dd
spl set id: 26a2ba34-eb41-614d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.