FDA.reportPublic FDA data

Benzalkonium Chloride

Manufacturer
PreCare Corp.
Effective date
2022-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:56

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Uses

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

Warnings

Warnings

For external use only.

Directions And Dosage

Directions

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

Other Label Information

Inactive ingredients

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

Questions?

call 718-975-2586

Principal Display Panel

Label Images#

BioPure Wipes
BioPure Wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD4
1038558benzalkonium chloride 0.13 % Topical ClothSY4
1038558benzalkonium chloride 0.13 % Topical SwabSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53118-140-042024-01-30C16284748780-11030e365-35c0-111a-e063-dadaa90a10e2Antibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53118-140-04Benzalkonium Chloride1400 in 1 CONTAINERCLOTH14004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53118-140BENZALKONIUM CHLORIDE (ANTIBACTERIAL HAND WIPES) CLOTH [PRECARE CORP.]4Legacy NDC, 1 package rows20221130_d804dbef-0db1-9271-e053-2995a90abe51.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53118-14053118-140-04

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Complete SPL Sections#

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.

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

Source Document#

Source XML