REFILL 2- benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Refill 2 by

Drug Labeling and Warnings

Refill 2 by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use

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

Warnings

For external use only.

Do not use

in the eyes over large areas of the body if you are allergic to any of the ingredient longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

deep or punture wounds animal bites serious burns.

Stop use and ask a doctor if

the condition persists or gets worse a rash or other allergic reaction develops.

Keep out of reach of children.

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

Directions

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

Other information

Store at room temperature

Inactive ingredients

Mineral oil, petrolatum, purified water

DRUG FACTS

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Use:

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

Warnings

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

In the eyes, or over large areas of the body.

Directions:

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

Inactive ingredient:

Purified water.

Antibiotic Application (

50814-013-01) Labeling:

Antiseptic Towelettes (

50814-011-01) Labeling:

Refill 2 (

50814-016-01) Labeling:

INGREDIENTS AND APPEARANCE

REFILL 2 
benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-016

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-016-01	1 in 1 KIT	08/10/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	20 PATCH	18 g
Part 2	10 PACKET	9 g

Part 1 of 2

ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth

Product Information
Item Code (Source)	NDC: 50814-011
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: 50814-011-01	2 in 1 BOX
1		10 in 1 BOX
1		0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/10/2016

Part 2 of 2

ANTIBIOTIC APPLICATION 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 50814-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-013-01	1 in 1 BOX
1		10 in 1 BOX
1		0.9 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 final	part333B	08/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/10/2016

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

Establishment
Name	Address	ID/FEI	Business Operations
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture(50814-016, 50814-011, 50814-013)