Antiseptic Hand Sanitizer

Manufacturer
Laboratorios Zeyco, S.A. de C.V.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:02

Label at a glance#

ProductAntiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire and flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at no more than 86ºF (30ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aminomethyl propanol, carbomer, glycerin, water.

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:125ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63710-004-00Antiseptic Hand Sanitizer500 mL in 1 BOTTLEGEL5002
63710-004-01Antiseptic Hand Sanitizer125 mL in 1 BOTTLEGEL1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63710-004ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [LABORATORIOS ZEYCO, S.A. DE C.V.]2Current NDC, Legacy NDC, 2 package rows20231027_ad14b387-e280-8dab-e053-2995a90a590c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63710-00463710-004-00, 63710-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
Antiseptic Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.ad14b387-e280-8dab-e053-2995a90a590c2023-10-26WarningsExact identifier
ndc (package): 63710-004-00
ndc (package): 63710-004-01
ndc (product): 63710-004
ndc11 (package): 63710000400
ndc11 (package): 63710000401
spl id: 08a16eed-ba0f-b1fa-e063-6294a90a6615
spl set id: ad14b387-e280-8dab-e053-2995a90a590c

Reported adverse events (FAERS/openFDA)#

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