FDA.reportPublic FDA data

Berkley Jenson Antibacterial Hand

Manufacturer
BJWC | Apollo Health and Beauty Care Inc.
Effective date
2020-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:59

Label at a glance#

ProductBerkley Jenson Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

helps eliminate bacteria on hands.

Dosage and administration

appy onto wet hands. Lather and rinse thoroughly

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

helps eliminate bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact, rinse with water.

Stop use and ask a 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

appy onto wet hands. Lather and rinse thoroughly

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Poloxamer 124, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Camellia Sinensis Leaf Extract, Saccharomyces Ferment, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-934-1204

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-151-642024-01-30C16284748780-11030e365-0d5d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-151-64Berkley Jenson Antibacterial Hand1892 mL in 1 BOTTLE, PLASTICLIQUID18921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-151BERKLEY JENSON ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [BJWC]1Legacy NDC, 1 package rows20200318_0927b5a2-6f47-4e3b-997a-e7f4ce1df7d9.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68391-15168391-151-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)X70SE62ZARIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLOXAMER 1241S66E28KXAIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SACCHAROMYCES LYSATER85W246Z1CIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ASCORBYL PALMITATEQN83US2B0NIACT
NIACINAMIDE25X51I8RD4IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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
f0e8d90a-633c-48c9-a917-52a2ba2668330927b5a2-6f47-4e3b-997a-e7f4ce1df7d92020-03-17WarningsExact identifier
spl id: f0e8d90a-633c-48c9-a917-52a2ba266833
spl set id: 0927b5a2-6f47-4e3b-997a-e7f4ce1df7d9

Reported adverse events (FAERS/openFDA)#

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