FDA.reportPublic FDA data

BlisterZone

Manufacturer
MedZone Products LLC | Richard Hamer Associates LLC | Biomed Laboratories LLC | MicroConsult Inc | Ceutical Laboratories Inc
Effective date
2018-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:28

Label at a glance#

ProductBlisterZone
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Back PanelBack PanelFor 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 chlidren

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 Vera Leaf, Alpha-Tocopheryl Acetate, 1-Butene, C18-36 Acid Triglyceride, Ethylene, Eucalyptus Oil, Ginkgo, Levomenol, Medium-Chain Triglycerides, Menthyl Lactate, Methylparaben, Mineral oil, Peppermint Oil, Petrolatum, Propylene, Propylparaben, Styrene, Tea Tree Oil, Tribehenin, Yellow Wax

Other Information

OTHER SAFETY INFORMATION

Store at room temperature. Avoid excessive heat.

Questions?

OTC - QUESTIONS SECTION

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

www.medzonecorp.com info@medzonecorp.com

HOW SUPPLIED SECTION

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

All rights reserved

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BlitserzonePDPBlitserzonePDP

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130684396631002GTIN-13: 0684396631002
EAN-13: 0684396631002
GTIN-12: 684396631002
UPC-A: 684396631002
GTIN storage (14 digits): 00684396631002		BlisterZoneBackLabel0216.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-611-002023-07-28C16284748780-10191ceaa-6d55-198a-e063-dbdaa90aec3e3760752a-1d84-5d45-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-611-00BlisterZone23 g in 1 APPLICATORSTICK232

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-611BLISTERZONE (SKIN PROTECTANT) STICK [MEDZONE PRODUCTS LLC]2Legacy NDC, 1 package rows20180212_3760752a-1d84-5d45-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70338-61170338-611-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEPPERMINT OILAV092KU4JHIACT
STYRENE44LJ2U959VIACT
TRIBEHENIN8OC9U7TQZ0IACT
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
1-BUTENELY001N554LIACT
ETHYLENE91GW059KN7IACT
DIMETHICONE92RU3N3Y1OACTIB
C18-36 ACID TRIGLYCERIDEZRA72DR3R7IACT
EUCALYPTUS OIL2R04ONI662IACT
GINKGO19FUJ2C58TIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENEAUG1H506LYIACT
PROPYLPARABENZ8IX2SC1OHIACT
TEA TREE OILVIF565UC2GIACT

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
650889c6-2c80-7368-e053-2991aa0a77203760752a-1d84-5d45-e054-00144ff88e882018-02-12WarningsExact identifier
spl id: 650889c6-2c80-7368-e053-2991aa0a7720
spl set id: 3760752a-1d84-5d45-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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