FDA.reportPublic FDA data

Benzalkonium Chloride

Manufacturer
Quest USA Corp
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:20:26

Label at a glance#

ProductBenzalkonium Chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria For use when soap and water are not available

Dosage and administration

Apply to hands, allow to air dry without wiping. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria
  • For use when soap and water are not available

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months old.
  • on open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to hands, allow to air dry without wiping.
  • Children under 6 years of age should be supervised when using this product.

Other information

OTHER SAFETY INFORMATION

  • Store in a cool, dry place, between 15°-30°C (59°F-86°F).
  • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Citric Acid, Decyl Glucoside, Disodium EDTA, Fragrance, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Benzoate

Questions?

OTC - QUESTIONS SECTION

call 718-975-2586

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioPure

ANTIBACTERIAL

Hand Wipes

NET CONTENTS:

1400

Wipes

1600

Wipes

frontfront

backback

frontfront

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN11
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD11
1038558benzalkonium chloride 0.13 % Topical ClothSY11
1038558benzalkonium chloride 0.13 % Topical SwabSY11
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY11
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY11
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-140-04Benzalkonium Chloride1400 in 1 CONTAINERCLOTH140011
78691-140-06Benzalkonium Chloride1600 in 1 CONTAINERCLOTH160011

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
78691-14078691-140-04, 78691-140-06

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
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
ndc (package): 78691-140-04
ndc (package): 78691-140-06
ndc (product): 78691-140
ndc11 (package): 78691014006
ndc11 (package): 78691014004
spl id: 453a5e32-8a03-f152-e063-6294a90a3087
spl set id: d9ab219d-07e3-2019-e053-2a95a90a1668

Reported adverse events (FAERS/openFDA)#

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