FDA.reportPublic FDA data

Model AA-2012

Manufacturer
AEROSPACE ACCESSORY SERVICE | LernaPharm Loris Inc
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:37

Label at a glance#

ProductModel AA-2012
Active ingredientBENZALKONIUM CHLORIDE
Label structure19 sections

Indications and uses

First Aid Antiseptic

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#

Antiseptic Wipes Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v

Antiseptic Wipes Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Antiseptic Wipes Uses

INDICATIONS & USAGE SECTION

First Aid Antiseptic

Antiseptic Wipes Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use it 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 it for longer than 1 week unless directed by a doctor.

Antiseptic Wipes 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.

Antiseptic Wipes 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.

Antiseptic Wipes Other information

OTHER SAFETY INFORMATION

  • store at room temperature between 59-86 F
  • If contact with eyes occurs, flush eyes with water

Antiseptic Wipes Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water

Antiseptic Wipes Questions

OTC - QUESTIONS SECTION

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

BZK Pads Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v

BZK Pads Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

BZK Pads Uses

INDICATIONS & USAGE SECTION

First aid to help prevent skin infection in minor cuts, scrapes and burns

BZK Pads Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • As an antiseptic for more than 1 week
  • In the eyes

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

deep puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develop
  • Condition persistor gets worse

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 ( 1-800-222-1222) right away

BZK Pads Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • May be covered with a sterile bandage
  • If bandaged, let dry first

BZK Pads Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature 15-30C (59-86F)
  • Avoid excessive heat
  • Temper evident. Do not use if packet is torn or cut

BZK Pads Inactive ingredients

IMMUNOGENICITY

Water, may contain Methylchloroisothiazolinone/Methlylisothiazolinone

BZK Pads Questions

OTC - QUESTIONS SECTION

1-800-DYNAREX Monday-Friday 9AM-5PM EST

Antiseptic Wipes Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

BZK Pads Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Model AA-2012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27860-014-01Model AA-20121 in 1 KITKIT13
67777-245-01Model AA-20120.55 mL in 1 PACKETSWAB1.3 mL1.3 mg in 1mL3
67777-245-01Model AA-2012100 in 1 BOXSWAB1.3 mg in 1mL3
68356-126-02Model AA-20122.6 g in 1 PACKETSWAB0.13 g in 1000.13 g in 100g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27860-014MODEL AA-2012 KIT [AEROSPACE ACCESSORY SERVICE]3Current NDC, Legacy NDC, 4 package rows20241004_e29b0f92-27b7-e09f-e053-2995a90a35e3.zip
67777-245MODEL AA-2012 KIT [AEROSPACE ACCESSORY SERVICE]3Current NDC, Legacy NDC20241004_e29b0f92-27b7-e09f-e053-2995a90a35e3.zip
68356-126MODEL AA-2012 KIT [AEROSPACE ACCESSORY SERVICE]3Current NDC, Legacy NDC20241004_e29b0f92-27b7-e09f-e053-2995a90a35e3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-245-01EA - Each67777-245f06d51c9-0969-4fdd-87dd-2c7c435a4b2a12019-01-24
67777-245-02EA - Each67777-2451a8a84f8-e97d-4f54-93ba-58f43c0f7f4012019-01-24
67777-245-11EA - Each67777-24592166bbd-cfa0-4913-82a0-d4f1e0a7651012023-08-08

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27860-01427860-014-01
68356-12668356-126-02
67777-24567777-245-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
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 · 3 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): 68356-126-02
ndc (product): 68356-126
ndc11 (package): 68356012602
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation1409c437-ff17-481d-94be-87dd6d463ba92026-01-28WarningsExact identifier
ndc (package): 67777-245-01
ndc (product): 67777-245
ndc11 (package): 67777024501
Model AA-2012MODEL AA-2012AEROSPACE ACCESSORY SERVICEe29b0f92-27b7-e09f-e053-2995a90a35e32024-10-01WarningsExact identifier
ndc (package): 67777-245-01
ndc (package): 27860-014-01
ndc (package): 68356-126-02
ndc (product): 27860-014
ndc11 (package): 67777024501
ndc11 (package): 27860001401
ndc11 (package): 68356012602
spl id: 236e1247-19d0-e131-e063-6394a90a8c82
spl set id: e29b0f92-27b7-e09f-e053-2995a90a35e3

Reported adverse events (FAERS/openFDA)#

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