FDA.reportPublic FDA data

ZYTEC

Manufacturer
Empack
Effective date
2011-01-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:51:50

Label at a glance#

ProductZYTEC GERM BUSTER HAND SANITIZER
Active ingredientETHANOL
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

OTC - WHEN USING SECTION

  • For handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame.

WARNINGS AND PRECAUTIONS SECTION

Contents under pressure

WARNINGS AND PRECAUTIONS SECTION

Do not puncture of incinerate

WARNINGS AND PRECAUTIONS SECTION

Do not expose to heat or store at temperatures above 120oF / 50oC or in enclosed places that could overheat.

WARNINGS AND PRECAUTIONS SECTION

Do not use in or near eyes.  In case of contact rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if, irritation and redness develop and persists for more than 72 hours

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

INDICATIONS & USAGE SECTION

  • spray in palm of hand ans rub over entire surface of hands
  • briskly rub hands together until dry
  • supervise children in the use of this product

DOSAGE & ADMINISTRATION SECTION

  • spray product generously over hands, rub together until product drys.

Other Information

OTC - WHEN USING SECTION

  • may discolor certain fabric

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua) , Isobutene, Fragrance,

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM2
product label
product label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130060480010463GTIN-13: 0060480010463
EAN-13: 0060480010463
GTIN-12: 060480010463
UPC-A: 060480010463
GTIN storage (14 digits): 00060480010463		bottle label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50021-080-082025-02-10C16284748780-1960f7f55-c077-8e05-e053-dbdaa90a074aDrug Facts for an OTC Aerosol Hand Sanitizer
50021-080-092025-02-10C16284748780-1960f7f55-c077-8e05-e053-dbdaa90a074aDrug Facts for an OTC Aerosol Hand Sanitizer
50021-080-082019-10-29C16284748780-1960f7f55-c077-8e05-e053-dbdaa90a074aDrug Facts for an OTC Aerosol Hand Sanitizer
50021-080-092019-10-29C16284748780-1960f7f55-c077-8e05-e053-dbdaa90a074aDrug Facts for an OTC Aerosol Hand Sanitizer

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ETHANOLACTIVE INGREDIENT3K9958V90M5
ETHANOLACTIVE MOIETY3K9958V90M5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50021-08050021-080-08, 50021-080-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHANOL3K9958V90MACTIB
WATER059QF0KO0RIACT

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
296684d0-407a-c0dc-e063-6294a90a67b4283cdcc1-0c4c-11e0-81e0-0800200c9a662025-02-10WarningsExact identifier
spl set id: 283cdcc1-0c4c-11e0-81e0-0800200c9a66

Reported adverse events (FAERS/openFDA)#

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