FDA.reportPublic FDA data

Berkley Jensen Instant Hand Sanitizer

Manufacturer
BJWC | Apollo Health and Beauty Care Inc.
Effective date
2020-03-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:58

Label at a glance#

ProductBerkley Jensen Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

to help reduce bacteria on the skin.

Dosage and administration

wet hands thoroughly and rub together until dry.

Storage and handling

store at a temperature below 110°F (43°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable
  • Keep away from source of heat or fire.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask doctor if 

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

wet hands thoroughly and rub together until dry.

Other information

STORAGE AND HANDLING SECTION

store at a temperature below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-934-1204

Label Copy 2 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the label 2 ozimage of the label 2 oz

Label Copy 12 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the label 12 ozimage of the label 12 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-168-022024-01-30C16284748780-11030e365-0770-111a-e063-dadaa90a10e2Drug Facts
68391-168-082024-01-30C16284748780-11030e365-0770-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-168-02Berkley Jensen Instant Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
68391-168-08Berkley Jensen Instant Hand Sanitizer354 mL in 1 BOTTLE, PLASTICGEL3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-168BERKLEY JENSEN INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [BJWC]1Legacy NDC, 2 package rows20200317_7f068b75-409b-4fb1-b455-8358322563ec.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
68391-16868391-168-02, 68391-168-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
5265ddb4-5f61-4dd7-ad67-2d4d474270fa7f068b75-409b-4fb1-b455-8358322563ec2020-03-16WarningsExact identifier
spl id: 5265ddb4-5f61-4dd7-ad67-2d4d474270fa
spl set id: 7f068b75-409b-4fb1-b455-8358322563ec

Reported adverse events (FAERS/openFDA)#

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