FDA.reportPublic FDA data

Loris BZK

Manufacturer
LernaPharm Loris Inc.
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:49:11

Label at a glance#

ProductLoris BZK Antiseptic Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Dosage and administration

Tear open pouch and use as part of your daily cleansing routine. Clean the affected area. Apply this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride, 0.13% v/v

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For External Use Only

SPL UNCLASSIFIED SECTION

  • Do not use in the eyes or apply over large areas of the body.
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • Stop use and consult a doctor if the condition persists or gets worse.
  • Do not use for longer than 1 week unless directed by a doctor.

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

  • Tear open pouch and use as part of your daily cleansing routine.
  • Clean the affected area.
  • Apply this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature between 59-86 oF (15-30 oC). If contact with eyes occurs, flush eyes with water.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Place holder text



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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN13
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD13
1038558benzalkonium chloride 0.13 % Topical ClothSY13
1038558benzalkonium chloride 0.13 % Topical SwabSY13
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY13
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY13
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68356-126-01Loris BZKAntiseptic Wipes100 in 1 BOXSWAB10013
68356-126-01Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613
68356-126-02Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613
68356-126-03Loris BZKAntiseptic Wipes2.5 g in 1 APPLICATORSWAB2.513
68356-126-03Loris BZKAntiseptic Wipes3 in 1 PACKAGESWAB313
68356-126-04Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W78
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y8
WATERINACTIVE INGREDIENT059QF0KO0R8

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68356-12668356-126-02, 68356-126-04, 68356-126-01, 68356-126-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
ndc (package): 68356-126-03
ndc (package): 68356-126-04
ndc (package): 68356-126-02
ndc (package): 68356-126-01
ndc (product): 68356-126
ndc11 (package): 68356012603
ndc11 (package): 68356012601
ndc11 (package): 68356012602
ndc11 (package): 68356012604
spl id: 4c4e2cec-ba7a-093f-e063-6294a90ad793
spl set id: a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2
Model AA-2012MODEL AA-2012AEROSPACE ACCESSORY SERVICEe29b0f92-27b7-e09f-e053-2995a90a35e32024-10-01WarningsExact identifier
ndc (package): 68356-126-02
ndc11 (package): 68356012602

Reported adverse events (FAERS/openFDA)#

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