FAK CARE4 BUS AND SCHOOL YELLOW ORM D- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol kit

FAK Care4 Bus and School Yellow ORM D by

Drug Labeling and Warnings

FAK Care4 Bus and School Yellow ORM D by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

First Aid Antibiotic Ointment, 0.9g (

50814-007-01) Drug Facts

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

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

Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients

longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

deep or puncture 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

First Aid Antiseptic Pain Relieving Cream, 0.9g (

50814-009-01) Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5

Purpose

First aid antiseptic

Pain relieving cream

Uses

• First aid to help prevent infection in minor cuts, scrapes, and burns.
• For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.

Warnings

For external use only.

Do not use

in the eyes over large areas of the body in large quantities over raw surfaces or blistered areas longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds animal bites serious burns.

Stop use and ask a doctor if

the condition persists or gets worse symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

• Clean the affected area
• Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
• Children under 2 years of age: consult a doctor
• May be covered with a sterile bandage

Other information

Store at room temperature

Inactive ingredients

glycerin monostearate, glycerol, purified water

Alcohol Cleansing Pad (50814-001-01) DRUG FACTS

Active ingredient:

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use:

For preparation of the skin before injection.

Warnings:

For external use only.

Flammable: keep away from fire or flame.

Do not use:

with electrocautery, in the eyes

Stop use

if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor.

Keep out of reach of children.

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

Directions:

Wipe injection site vigorously and discard.

Other information

Store at room temperature 15°-30° C (59°-86° F)

Inactive ingredient:

Purified water.

Antiseptic Towelette (

50814-002-01)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.

Insect Sting Relief Pad (52124-0008-1) DRUG FACTS

Active Ingredient:

Benzocaine, 6% w/v

SD alcohol,  60% w/v

Purpose

Topical Anesthetic
Antiseptic

Use:

For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings:

For external use only.

Do not use:

In eyes, on broken skin, deep puncture wounds. If unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately.

Keep out of reach of children.

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

Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

Inactive Ingredients:

Purified water.

Package Labeling:

First Aid Antibiotic Ointment, 0.9g

First Aid Antiseptic Pain Relieving Cream, 0.9g

Alcohol Cleansing Pad

Antiseptic Towelette

Insect Sting Relief Pad

INGREDIENTS AND APPEARANCE

FAK CARE4 BUS AND SCHOOL YELLOW ORM D 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-042

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-042-01	1 in 1 KIT	02/08/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BAG	0.9 g
Part 2	1 PACKAGE	0.9 g
Part 3	1 BAG	0.45 g
Part 4	1 POUCH	0.45 g
Part 5	1 POUCH	0.53 mL

Part 1 of 5

FIRST AID ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 50814-007
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		2 in 1 KIT
1	NDC: 50814-007-01	0.9 g in 1 BAG; 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	02/08/2018

Part 2 of 5

FIRST AID ANTISEPTIC PAIN RELIEVING 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC: 50814-009
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 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1	NDC: 50814-009-01	0.9 g 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	02/08/2018

Part 3 of 5

ALCOHOL CLEANSING 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 50814-039
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1	NDC: 50814-039-01	1 in 1 BOX
1		0.45 g in 1 BAG; 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	02/08/2018

Part 4 of 5

ANTISEPTIC TOWELETTE 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 50814-002
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		2 in 1 KIT
1	NDC: 50814-002-01	1 in 1 BOX
1		0.45 g in 1 POUCH; 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	02/08/2018

Part 5 of 5

INSECT STING RELIEF 
benzocaine, alcohol swab

Product Information
Item Code (Source)	NDC: 50814-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	60 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	600 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1	NDC: 50814-041-02	0.53 mL in 1 POUCH; 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	part348	06/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	02/08/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture(50814-042, 50814-007, 50814-009, 50814-039, 50814-002, 50814-041)