SUTURE SYRINGE MEDIC- benzalkonium chloride, alcohol kit

Suture Syringe Medic by

Drug Labeling and Warnings

Suture Syringe Medic by is a Otc medication manufactured, distributed, or labeled by Tender Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient - Antiseptic

Benzalkonium Chloride 0.13%

Purpose - Antiseptic

Antiseptic

Use - Antiseptic

For Professional and hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings, Precautions and Directions - Antiseptic

For External use only.

Keep out of Reach of Children.

Stop use if unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not uses in eyes or over large areas of the body.

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive Ingredients - Antiseptic

Purified Water

Active Ingredient - Alcohol Prep Pad

Isopropyl Alcohol 70%

Use - Alcohol Prep Pad

For preparation of the skin before injection

Warnings, Precautions and Directions - Alcohol Prep Pad

For External Use Only

Flammable - Keep away from fire or flame

Do Not Use - with electrocautery, in eyes

Stop Use and Ask a Doctor if - Irritation or redness develop and persists for more than 72 hours

Keep out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Tear Open packet, unfold and use as and wipe injection site vigorously and discard.

Store at Room Temperature

Keep out of Reach of Children

Keep out of Reach of Children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUTURE SYRINGE MEDIC 
benzalkonium chloride, alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-0468

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-0468-1	1 in 1 BOX; Type 0: Not a Combination Product	10/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKAGE	3 mL  in .7
Part 2	4 PACKAGE	3 mL  in .8

Part 1 of 2

ALCOHOL PREP PAD 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 52124-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0017-1	0.7 mL in 1 PACKAGE; 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	02/01/2016

Part 2 of 2

ANTISEPTIC 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 52124-0001
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0001-1	0.8 mL in 1 PACKAGE; 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	04/23/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2015

Labeler - Tender Corporation (064437304)

Registrant - Tender Corporation (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(44224-0468)