FDA.reportPublic FDA data

Problend Hand Sanitizer Gel

Manufacturer
Seatex, LLC
Effective date
2023-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:30

Label at a glance#

ProductProblend Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Ethanol 70% v/v....... Antiseptic

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of eye contact, flush eyes with water.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or cantact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Polyacrylidc Acid, Fragrance, Dye.

Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Stop Use Section

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and conditions persist for more than 72 hours.

Indications & Usage Section

Uses: For hand sanitizing to decrease bacteria on the skin.

Dosage and Administation Section

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product in your palm to thoroughly cover hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Warnings

WARNINGS SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PB0027139 Hand Sanitizer 1 GalPB0027139 Hand Sanitizer 1 Gal

Problend Hand Sanitizer Gel Label-Front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PB0027139-Hand Sanitizer-1.25-L-FRONT-LABELPB0027139-Hand Sanitizer-1.25-L-FRONT-LABEL

Problend Hand Sanitizer Gel Label-Back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PB0027139-Hand-Sanitizer-1.25-L-BACK-LABELPB0027139-Hand-Sanitizer-1.25-L-BACK-LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76250-140-012024-07-30C16284748780-11e7a6dab-1d33-a2ce-e063-dadaa90aadf7Formula 27139 Problend
76250-140-022024-07-30C16284748780-11e7a6dab-1d33-a2ce-e063-dadaa90aadf7Formula 27139 Problend
76250-140-032024-07-30C16284748780-11e7a6dab-1d33-a2ce-e063-dadaa90aadf7Formula 27139 Problend

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76250-140-01Problend Hand Sanitizer Gel1249000 mL in 1 CONTAINERGEL12490002
76250-140-02Problend Hand Sanitizer Gel125000 mL in 1 CARTRIDGEGEL1250002
76250-140-03Problend Hand Sanitizer Gel18900 mL in 1 BOTTLE, PLASTICGEL189002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76250-140PROBLEND HAND SANITIZER GEL (ETHANOL) GEL [SEATEX, LLC]23 package rows20230127_f319c0c7-1829-70ee-e053-2a95a90ac5ef.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
76250-14076250-140-01, 76250-140-02, 76250-140-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ALCOHOL3K9958V90MACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT

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
f32d1600-1e4f-642e-e053-2a95a90ad1bff319c0c7-1829-70ee-e053-2a95a90ac5ef2023-01-26WarningsExact identifier
spl id: f32d1600-1e4f-642e-e053-2a95a90ad1bf
spl set id: f319c0c7-1829-70ee-e053-2a95a90ac5ef

Reported adverse events (FAERS/openFDA)#

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