FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Pomok, S.A. de C.V.
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:32

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

KEEP OUT OF REACH OF CHILDREN

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

Supervise children under 6 years of age when using this product to avoid swallowing.

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTIMICROBIAL

Use[s]

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Warnings

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

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.

Store below 110°F (43°C)

WARNINGS

WARNINGS SECTION

Warnings

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70%

PACKAGE LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mLLABEL 250 mLLABEL 500 mLLABEL 500 mLLABEL 1000 mLLABEL 1000 mLLABEL 4000 mLLABEL 4000 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78354-0004-22022-01-28C16284748780-1d6a99b39-a763-a426-e053-dadaa90af4c2HAND SANITIZER 250 mL, 500 mL, 1000 mL, 4000 mL
78354-0004-42022-01-28C16284748780-1d6a99b39-a763-a426-e053-dadaa90af4c2HAND SANITIZER 250 mL, 500 mL, 1000 mL, 4000 mL
78354-0004-62022-01-28C16284748780-1d6a99b39-a763-a426-e053-dadaa90af4c2HAND SANITIZER 250 mL, 500 mL, 1000 mL, 4000 mL
78354-0004-82022-01-28C16284748780-1d6a99b39-a763-a426-e053-dadaa90af4c2HAND SANITIZER 250 mL, 500 mL, 1000 mL, 4000 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78354-0004-2HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78354-0004-4HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78354-0004-6HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
78354-0004-8HAND SANITIZER4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78354-0004HAND SANITIZER (ALCOHOL) GEL [POMOK, S.A. DE C.V.]1Legacy NDC, 4 package rows20200525_a6728e96-f92a-fdd8-e053-2a95a90a6b07.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
78354-000478354-0004-2, 78354-0004-4, 78354-0004-6, 78354-0004-8

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
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
a6728e96-f92b-fdd8-e053-2a95a90a6b07a6728e96-f92a-fdd8-e053-2a95a90a6b072020-05-25WarningsExact identifier
spl id: a6728e96-f92b-fdd8-e053-2a95a90a6b07
spl set id: a6728e96-f92a-fdd8-e053-2a95a90a6b07

Reported adverse events (FAERS/openFDA)#

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