FDA.reportPublic FDA data

Zytec Hand Sanitizer Wipes

Manufacturer
Empack Spraytech Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:27

Label at a glance#

ProductZytec Hand Sanitizer Wipes 80% w/w Alcohol
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product for 30 seconds and allow to dry without wiping. Discard after single use, do not flush in toilet. 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer wipes Alcohol 80% w/w

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol Wipes 80% w/w. 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

  • Wet hands thoroughly with product for 30 seconds and allow to dry without wiping. Discard after single use, do not flush in toilet.
  • 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 (Aqua), Fragrance (Aqua).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelHand Sanitizer Wipe 80% w/w Alcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2361646ethanol 80 % Medicated PadPSN5
2361646ethanol 0.8 ML/ML Medicated PadSCD5
2361646ethanol 80 % Medicated WipesSY5
2361646ethyl alcohol 80 % Topical ClothSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-014-05Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-05Zytec Hand Sanitizer Wipes80% w/w Alcohol35 in 1 CANISTERCLOTH355
50021-014-06Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-06Zytec Hand Sanitizer Wipes80% w/w Alcohol80 in 1 CANISTERCLOTH805
50021-014-07Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-07Zytec Hand Sanitizer Wipes80% w/w Alcohol100 in 1 CANISTERCLOTH1005
50021-014-08Zytec Hand Sanitizer Wipes80% w/w Alcohol800 in 1 PAILCLOTH8005
50021-014-08Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-09Zytec Hand Sanitizer Wipes80% w/w Alcohol55 in 1 CANISTERCLOTH555
50021-014-09Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-10Zytec Hand Sanitizer Wipes80% w/w Alcohol180 in 1 CANISTERCLOTH1805
50021-014-10Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-014ZYTEC HAND SANITIZER WIPES 80% W/W ALCOHOL (ALCOHOL) CLOTH [EMPACK SPRAYTECH INC.]5Current NDC, Legacy NDC, 12 package rows20241215_ab86fd0c-40cd-0bb6-e053-2a95a90a76e2.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50021-01450021-014-05, 50021-014-06, 50021-014-07, 50021-014-08, 50021-014-09, 50021-014-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
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
Zytec Hand Sanitizer Wipes 80% w/w AlcoholALCOHOLEmpack Spraytech Inc.ab86fd0c-40cd-0bb6-e053-2a95a90a76e22024-12-12WarningsExact identifier
ndc (package): 50021-014-06
ndc (package): 50021-014-09
ndc (package): 50021-014-08
ndc (package): 50021-014-10
ndc (package): 50021-014-07
ndc (package): 50021-014-05
ndc (product): 50021-014
ndc11 (package): 50021001406
ndc11 (package): 50021001408
ndc11 (package): 50021001409
ndc11 (package): 50021001407
ndc11 (package): 50021001410
ndc11 (package): 50021001405
spl id: 20af5fcb-c111-928a-e063-6294a90af852
spl set id: ab86fd0c-40cd-0bb6-e053-2a95a90a76e2

Reported adverse events (FAERS/openFDA)#

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