FDA.reportPublic FDA data

Zone Defense Foaming Hand Sanitizer

Manufacturer
Baer Enterprises, LLC
Effective date
2022-01-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:31

Label at a glance#

ProductZone Defense Foaming Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol 62% v/v. Purpose: Antiseptic

Isopropyl Alcohol 5% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyethylene Glycol Dimethicone, Caprylyl Glycol, Isopropyl Myristate, Glycerin, Tocopheryl Acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zone Defense Foaming Hand SanitizerZone Defense Foaming Hand Sanitizer18 fl. oz. (532 mL) NDC 73829-101-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2384138ethanol 62 % / isopropyl alcohol 5 % Topical FoamPSN3
2384138ethanol 0.62 ML/ML / isopropyl alcohol 0.05 ML/ML Topical FoamSCD3
2384138ethanol 62 % / isopropyl alcohol 5 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73829-101-182023-07-28C16284748780-10191ceaa-6668-198a-e063-dbdaa90aec3eaa808cfc-82dc-4bb1-e053-2995a90a91eb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73829-101-18Zone Defense Foaming Hand Sanitizer532 mL in 1 BOTTLE, PUMPLIQUID5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73829-101ZONE DEFENSE FOAMING HAND SANITIZER (ALCOHOL) LIQUID [BAER ENTERPRISES, LLC]3Legacy NDC, 1 package rows20220125_aa808cfc-82dc-4bb1-e053-2995a90a91eb.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73829-10173829-101-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d655bb58-7961-5555-e053-2a95a90a6442aa808cfc-82dc-4bb1-e053-2995a90a91eb2022-01-24WarningsExact identifier
spl id: d655bb58-7961-5555-e053-2a95a90a6442
spl set id: aa808cfc-82dc-4bb1-e053-2995a90a91eb

Reported adverse events (FAERS/openFDA)#

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