FDA.reportPublic FDA data

ANTI-BACTERIAL HAND GEL - 62% ETHYL ALCOHOL

Manufacturer
Pride Products Corp.
Effective date
2020-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:14:35

Label at a glance#

ProductANTI-BACTERIAL HAND
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

KILLS 99.9% OF GERMS ON SKIN

Dosage and administration

WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING THIS PRODUCT.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 62%

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USES

INDICATIONS & USAGE SECTION

KILLS 99.9% OF GERMS ON SKIN

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. FLAMMABLE.

KEEP AWAY FROM HEAT AND FLAME.

WHEN USING THIS PRODUCT: AVOID CONTACT WITH FACE, EYES, AND BROKEN SKIN. IN CASE OF EYE CONTACT, FLUSH WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE.

STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CARBOMER, VE, FLAVOR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Hand Sani Gel_38635_8oz01b LBL_Hand Sani Gel_38635_8oz

01b LBL_Hand Sani Gel_38635_2oz01b LBL_Hand Sani Gel_38635_2oz

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58037-10358037-103-08, 58037-103-02

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
d57be6ce-79d6-b625-e053-2a95a90a93a70d0568c7-27fe-42eb-b6b5-0b559e5a7eb72022-01-13WarningsExact identifier
spl set id: 0d0568c7-27fe-42eb-b6b5-0b559e5a7eb7

Reported adverse events (FAERS/openFDA)#

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