Model AA-2012 by AEROSPACE ACCESSORY SERVICE / LernaPharm Loris Inc MODEL AA-2012 kit

Model AA-2012 by

Drug Labeling and Warnings

Model AA-2012 by is a Otc medication manufactured, distributed, or labeled by AEROSPACE ACCESSORY SERVICE, LernaPharm Loris Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Antiseptic Wipes Active ingredient

Benzalkonium Chloride 0.13% v/v

Antiseptic Wipes Purpose

First Aid Antiseptic

Antiseptic Wipes Uses

First Aid Antiseptic

Antiseptic Wipes Warnings

For external use only

Do not use

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

If swallowed, get medical help or contact a Poison Control Center right away.

Antiseptic Wipes Directions

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

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

Antiseptic Wipes Inactive ingredients

Purified water

Antiseptic Wipes Questions

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

BZK Pads Active ingredient

Benzalkonium Chloride 0.13% v/v

BZK Pads Purpose

First Aid Antiseptic

BZK Pads Uses

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

BZK Pads Warnings

For external use only

Do not use

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

Ask a Doctor before use if you have

deep puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

• irritation or redness develop
• Condition persistor gets worse

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center ( 1-800-222-1222) right away

BZK Pads Directions

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

BZK Pads Other 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

Water, may contain Methylchloroisothiazolinone/Methlylisothiazolinone

BZK Pads Questions

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

Antiseptic Wipes Principal Display Panel

BZK Pads Principal Display Panel

Model AA-2012

INGREDIENTS AND APPEARANCE

MODEL AA-2012 
model aa-2012 kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27860-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27860-014-01	1 in 1 KIT	06/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 PACKET	0.13 g  in 100
Part 2	2 PACKET	1.3 mL

Part 1 of 2

LORIS BZK  ANTISEPTIC WIPES
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 68356-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-126-02	2.6 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/21/2012

Part 2 of 2

BZK PADS 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 67777-245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-245-01	100 in 1 BOX
1		0.55 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/05/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2022

Labeler - AEROSPACE ACCESSORY SERVICE (859100547)

Registrant - AEROSPACE ACCESSORY SERVICE (859100547)

Establishment
Name	Address	ID/FEI	Business Operations
LernaPharm Loris Inc		206940905	manufacture(27860-014)