FDA.reportPublic FDA data

benzalkonium chloride

Manufacturer
Cytonix, LLC | Elaine Lanza
Effective date
2020-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:01:42

Label at a glance#

Productbenzalkonium chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose Antiseptic. Hand and skin sanitizer.

INDICATIONS & USAGE SECTION

USES: To reduce bacteria on skin that could cause disease. Recommended for repeat use.

WARNINGS SECTION

WARNINGS

For external use only.

Do not use in eyes.

When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical attention or contact a Poison Control Center.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children.

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of eye contact flush with plenty of water.

OTC - STOP USE SECTION

Stop use and ask the doctor if irritation or redness develop.

INACTIVE INGREDIENT SECTION

3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Gylcerin, Water

DOSAGE & ADMINISTRATION SECTION

Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

OTC - QUESTIONS SECTION

Distributed by Drywired, LLc

Los Angeles, CA 90016

(800) 581-4528

www.drywired.com

Made by Cytonix, LLC

Beltsville, MD USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79291-656-01 Drywired Alcohol Free.jpg 79291-656-01 Drywired Alcohol Free79291-656-01 Drywired Alcohol Free

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79291-65679291-656-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDEGLJ50K866TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
b71314e2-0318-4e69-e053-2a95a90acc94b07c9b01-375a-064a-e053-2a95a90acaa52020-12-22WarningsExact identifier
spl set id: b07c9b01-375a-064a-e053-2a95a90acaa5

Reported adverse events (FAERS/openFDA)#

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