FDA.reportPublic FDA data

Prime

Manufacturer
Prime Industries Usa, Inc
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:58

Label at a glance#

ProductPrime
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% w/v

Purpose

OTC - PURPOSE SECTION

Antibacterial   

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

When using this product, avoid contact with eyes. In case of contact with eyes, flush with water.

Stop use and ask a doctor if irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

Label 3Label 3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79382-002-012022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-022022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-032022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-042022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-052022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-062022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841
79382-002-072022-01-28C16284748780-1d6a99b39-926c-a426-e053-dadaa90af4c235025154-cf81-407c-ae15-870298db2841

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79382-002-01Prime332 mL in 1 BOTTLE, PLASTICSOAP3321
79382-002-02Prime400 mL in 1 BOTTLE, PLASTICSOAP4001
79382-002-03Prime1000 mL in 1 BOTTLE, PLASTICSOAP10001
79382-002-04Prime2000 mL in 1 BOTTLE, PLASTICSOAP20001
79382-002-05Prime5000 mL in 1 BOTTLE, PLASTICSOAP50001
79382-002-06Prime100000 mL in 1 DRUMSOAP1000001
79382-002-07Prime200000 mL in 1 DRUMSOAP2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79382-002PRIME (BENZALKONIUM CHLORIDE) SOAP [PRIME INDUSTRIES USA, INC]1Legacy NDC, 7 package rows20200807_35025154-cf81-407c-ae15-870298db2841.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79382-00279382-002-01, 79382-002-02, 79382-002-03, 79382-002-04, 79382-002-05, 79382-002-06, 79382-002-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
GLYCERINPDC6A3C0OXIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
48ef28e8-41c9-4e3e-b656-de26f42deace35025154-cf81-407c-ae15-870298db28412020-08-04WarningsExact identifier
spl id: 48ef28e8-41c9-4e3e-b656-de26f42deace
spl set id: 35025154-cf81-407c-ae15-870298db2841

Reported adverse events (FAERS/openFDA)#

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