FDA.reportPublic FDA data

DiaSinc

Manufacturer
PureTek Corporation
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:35

Label at a glance#

ProductDiaSinc
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

■ a no-rinse topical antiseptic that protects against bacterial contamination

Dosage and administration

■ spray soiled and/or odorous (body and/or perineal) areas ■ gently wipe clean ■ repeat as necessary until all soils are removed and skin is clean ■ pat dry (no rinsing necessary)

Storage and handling

■ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. ■ protect from freezing ■ avoid excessive heat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ a no-rinse topical antiseptic that protects against bacterial contamination

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

■ deep or puncture wounds    ■ animal bites    ■ serious burns

When using this product

OTC - WHEN USING SECTION

■ do not get into eyes ■ If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ If irritation or redness develops ■ condition persists for more than 72 hours

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

■ spray soiled and/or odorous (body and/or perineal) areas ■ gently wipe clean ■ repeat as necessary until all soils are removed and skin is clean ■ pat dry (no rinsing necessary)

Other information

STORAGE AND HANDLING SECTION

■ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. ■ protect from freezing ■ avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis (aloe vera) leaf juice, aqua (purified water), butylene glycol, disodium EDTA, fragrance, GenRx Complex® [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], glycerin, phenoxyethanol, polysorbate 20, sodium hyaluronate, sodium hydroxide.

DiaSinc™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN2
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD2
1039012benzalkonium chloride 0.13 % Topical SpraySY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-596-16DiaSinc237 mL in 1 BOTTLE, SPRAYSPRAY2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-596DIASINC (BENZALKONIUM CHLORIDE) SPRAY [PURETEK CORPORATION]2Current NDC, 1 package rows20241004_d9ba1ca8-8883-11bb-e053-2995a90a5846.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-596-16ML - Milliliter59088-596fbe68773-ce5e-4b66-979d-0c76f2350a9012023-05-05

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-59659088-596-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
LEVOMENOL24WE03BX2TIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
MALTODEXTRIN7CVR7L4A2DIACT
NIACINAMIDE25X51I8RD4IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GINGERC5529G5JPQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
ndc (package): 59088-596-16
ndc (product): 59088-596
ndc11 (package): 59088059616
spl id: 2385c911-b836-5c8c-e063-6394a90ad257
spl set id: d9ba1ca8-8883-11bb-e053-2995a90a5846

Reported adverse events (FAERS/openFDA)#

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