FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GORDON LABORATORIES,INC
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:22

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

Dosage and administration

DISPENSE ONE PUMP OF SANITIZER ON- TO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UN- DER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

Storage and handling

STORE BELOW 110 (DEGREES FAHREN- HEIT). MAY CAUSE DISCOLORATON TO CERTAIN FABRICS AND SURFACES

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

USES:

INDICATIONS & USAGE SECTION

HELPS REDUCE BACTERIA ON THE SKIN.

RECOMMENDED FOR REPEATED USE.

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. FLAMMABLE

KEEP AWAY FROM FIRE OR FLAME.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT, AVOID

CONTACT WITH EYES. IN CASE OF CON-

TACT WITH EYES, FLUSH THOROUGHLY

WITH WATER. AVOID CONTACT WITH

BROKEN SKIN.

OTC - STOP USE SECTION

STOP USE AND ASK DOCTOR IF IRRITA-

TION OR REDNESS DEVELOPS, OR IF

CONDITION PERSISTS FOR MORE THAN

72 HOURS.

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

DISPENSE ONE PUMP OF SANITIZER ON-

TO HANDS AND RUB TOGETHER UNTIL

DRY. USE AS NEEDED. FOR CHILDREN UN-

DER 6, USE WITH ADULT SUPERVISION.

NOT RECOMMENDED FOR INFANTS.

OTHER INFO:

STORAGE AND HANDLING SECTION

STORE BELOW 110 (DEGREES FAHREN-

HEIT). MAY CAUSE DISCOLORATON TO

CERTAIN FABRICS AND SURFACES

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION


DENATURED DEHYDRATED ALCOHOL
40B, WATER, ALOE BARBADENSIS (AL-
OE VERA) LEAF JUICE, GLYCERIN, PRO-

PYLENE GLYCOL, CARBOMER, PRO-

PANEDIOL, 2-AMINO METHYL-1 PROPA-

NOL SOLUTION, TOCOPHERYL ACE-

TATE (VITAMIN E ACETATE), HELIAN-

THUS ANNUUS (SUNFLOWER) SEED OIL
(AND) VACCINIUM MACROCARPON
(CRANBERRY) FRUIT EXTRACT (AND)
PUNICA GRANATUM EXTRACT (AND)
VACCINIUM AN-GUSTIFOLIUM (BLUE-

BERRY) EXTRACT (AND) FRAGARIA
VESCA (STRAWBERRY) FRUIT EXTRACT
(AND) ACTINIDIA CHINENSIS (KIWI) E,
SIMMONDSIA CHINENSIS.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC 21839-845-01 236 mL NDC 21839-845-01236 mL NDC 21839-845-01

236 mL NDC 21839-845-02236 mL NDC 21839-845-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860080ethanol 62.5 % Topical GelPSN1
1860080ethanol 0.625 ML/ML Topical GelSCD1
1860080ethanol 62.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-845-012022-01-28C16284748780-1d6a99b39-5668-a426-e053-dadaa90af4c2ARTNATURALS SCENT FREE HAND SANITIZER
21839-845-022022-01-28C16284748780-1d6a99b39-5668-a426-e053-dadaa90af4c2ARTNATURALS SCENT FREE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-845-01Hand Sanitizer236 mL in 1 BOTTLEGEL2361
21839-845-02Hand Sanitizer236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-845HAND SANITIZER (ALCOHOL) GEL [GORDON LABORATORIES,INC]1Legacy NDC, 2 package rows20200502_a49dce46-894f-1bff-e053-2995a90a4225.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-84521839-845-01, 21839-845-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
BLUEBERRY253RUG1X1AIACT
POMEGRANATE56687D1Z4DIACT
CRANBERRY0MVO31Q3QSIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
KIWI FRUIT71ES77LGJCIACT
JOJOBA OIL724GKU717MIACT
TEA TREE OILVIF565UC2GIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SUNFLOWER OIL3W1JG795YIIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FRAGARIA VESCA FRUITCG6IX3GCMUIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

Source Document#

Source XML · Source PDF

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
a49d3d55-6e74-18a6-e053-2995a90a15d8a49dce46-894f-1bff-e053-2995a90a42252020-05-01WarningsExact identifier
spl id: a49d3d55-6e74-18a6-e053-2995a90a15d8
spl set id: a49dce46-894f-1bff-e053-2995a90a4225

Reported adverse events (FAERS/openFDA)#

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