FDA.reportPublic FDA data

pre fense unscented

Manufacturer
Prefense LLC | Reynolds Engineering
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:17:36

Label at a glance#

Productpre fense unscented
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Hand and Skin Sanitizer

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride ............0.12%

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce germs that potentially cause disease.

WARNINGS SECTION

For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Apply to dry hands, rub together, and let dry.

INACTIVE INGREDIENT SECTION

3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water

Package Label - 1.5 FL. OZ. BOTTLE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pre•fense ™

Hand Sanitizer

Unscented

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

alcohol-free

won't dry out skin

120 Pumps

1.5 fl. oz.

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSN7
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCD7
1052949benzalkonium chloride 0.12 % Topical SolutionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130812551020006GTIN-13: 0812551020006
EAN-13: 0812551020006
GTIN-12: 812551020006
UPC-A: 812551020006
GTIN storage (14 digits): 00812551020006		Prefense_HS_Label_1.5oz_UnSc_ol.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48404-050-01pre fense unscented44.4 mL in 1 BOTTLELIQUID44.47
48404-050-02pre fense unscented236.6 mL in 1 BOTTLELIQUID236.67
48404-050-03pre fense unscented502.8 mL in 1 BOTTLELIQUID502.87
48404-050-04pre fense unscented236.6 mL in 1 BOTTLELIQUID236.67
48404-050-04pre fense unscented3 in 1 PACKAGELIQUID37
48404-050-05pre fense unscented6 in 1 PACKAGELIQUID67
48404-050-05pre fense unscented44.4 mL in 1 BOTTLELIQUID44.47

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
48404-05048404-050-01, 48404-050-02, 48404-050-03, 48404-050-04, 48404-050-05

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
(3-CHLOROPROPYL)TRIMETHOXYSILANET21BNL1S7FIACT
ISOTONIC SODIUM CHLORIDE SOLUTIONVR5Y7PDT5WIACT
METHYL ALCOHOLY4S76JWI15IACT
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
ACETIC ACIDQ40Q9N063PIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
pre fense unscentedBENZALKONIUM CHLORIDEPrefense LLCa59e9bbf-b60e-970a-e053-2a95a90aaa5e2025-11-21WarningsExact identifier
ndc (package): 48404-050-03
ndc (package): 48404-050-02
ndc (package): 48404-050-05
ndc (package): 48404-050-01
ndc (package): 48404-050-04
ndc (product): 48404-050
ndc11 (package): 48404005005
ndc11 (package): 48404005002
ndc11 (package): 48404005003
ndc11 (package): 48404005001
ndc11 (package): 48404005004
spl id: 4428ab74-189c-d384-e063-6294a90ad56b
spl set id: a59e9bbf-b60e-970a-e053-2a95a90aaa5e

Reported adverse events (FAERS/openFDA)#

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