FDA.reportPublic FDA data

Grabpak Antibacterial Hand

Manufacturer
Lyte Ltd
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:00

Label at a glance#

ProductGrabpak Antibacterial Hand
Active ingredientCHLOROXYLENOL
Label structure6 sections

Dosage and administration

Apply onto wet hands, lather for at least 30 seconds and rinse thoroughly. To refill a small size bottle, pour as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antibacterial 

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if 

OTC - STOP USE SECTION

irritation or redness develops.

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

  • Apply onto wet hands, lather for at least 30 seconds and rinse thoroughly.
  • To refill a small size bottle, pour as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, FRAGRANCE, DMDM HYDANTION, CITRIC ACID, DISODIUM EDTA, DYE.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN1
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD1
413261chloroxylenol 0.3 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80621-000-162022-01-28C16284748780-1d6a99b39-7c47-a426-e053-dadaa90af4c2Grabpak Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80621-000-16Grabpak Antibacterial Hand473 mL in 1 BOTTLE, PUMPSOAP4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80621-000GRABPAK ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [LYTE LTD]1Legacy NDC, 1 package rows20201005_afd3d4ed-4dd4-735d-e053-2a95a90a453f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80621-00080621-000-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
COCOYL METHYL MONOETHANOLAMINE79G1T427CFIACT
SODIUM CHLORIDE451W47IQ8XIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
afd3d4ed-4dd5-735d-e053-2a95a90a453fafd3d4ed-4dd4-735d-e053-2a95a90a453f2020-09-21WarningsExact identifier
spl id: afd3d4ed-4dd5-735d-e053-2a95a90a453f
spl set id: afd3d4ed-4dd4-735d-e053-2a95a90a453f

Reported adverse events (FAERS/openFDA)#

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