FDA.reportPublic FDA data

Berkley Jensen

Manufacturer
BJWC | Apollo Health and Beauty Care Inc.
Effective date
2017-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:06

Label at a glance#

ProductBerkley Jensen Instant 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

Label Copy

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
884783ethanol 65 % Topical SolutionPSN1
884783ethanol 0.65 ML/ML Topical SolutionSCD1
884783ethanol 65 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-167-032020-01-31C16284748780-19d75b9d0-5fce-f424-e053-dadaa90a57ceDrug Facts
68391-167-132020-01-31C16284748780-19d75b9d0-5fce-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-167-03Berkley JensenInstant Sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
68391-167-13Berkley JensenInstant Sanitizer354 mL in 1 BOTTLE, PLASTICLIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-167BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]1Legacy NDC, 2 package rows20170731_aaa084bb-3a38-4fea-a2f6-9301a5ce2f49.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
68391-16768391-167-03, 68391-167-13

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
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT

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
6969bdb6-7dd0-4a54-af1c-7b9de38c5515aaa084bb-3a38-4fea-a2f6-9301a5ce2f492017-07-31WarningsExact identifier
spl id: 6969bdb6-7dd0-4a54-af1c-7b9de38c5515
spl set id: aaa084bb-3a38-4fea-a2f6-9301a5ce2f49

Reported adverse events (FAERS/openFDA)#

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