CARE BUS AND CLASSROOM YELLOW- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol
CMC Group, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kit Care4 Bus & Classroom Yellow

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:

Kit0

First Aid Antibiotic Ointment, 0.9g

First Aid Antibiotic

First Aid Antiseptic Pain Relieving Cream, 0.9g

First Aid Antiseptic Pain

Alcohol Cleansing Pad

Antiseptic Towelette

Insect Sting Relief Pad

CARE BUS AND CLASSROOM YELLOW
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:49687-0025

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49687-0025-0	1 in 1 KIT	02/13/2018	10/31/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 BAG	1.8 g
Part 2	2 PACKAGE	1.8 g
Part 3	2 BAG	0.9 g
Part 4	2 POUCH	0.9 g
Part 5	2 PACKAGE	1 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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description
Packaging
1		2 in 1 KIT
1	NDC:50814-007-01	0.9 g in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	02/13/2018	10/31/2020

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description
Packaging
1		2 in 1 KIT
1	NDC:50814-009-01	0.9 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/13/2018	10/31/2020

Part 3 of 5

ALCOHOL CLEANSING
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC:50814-039
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/13/2018	10/31/2020

Part 4 of 5

ANTISEPTIC TOWELETTE
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC:50814-002
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/13/2018	10/31/2020

Part 5 of 5

INSECT STING RELIEF PAD
benzocaine,alcohol swab

Product Information
Item Code (Source)	NDC:52124-0008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.6 mg in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL in 100 mL

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

#	Item Code	Package Description
Packaging
1		2 in 1 KIT
1	NDC:52124-0008-1	0.5 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/13/2018	10/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/13/2018	10/31/2020

Labeler - CMC Group, Inc. (005583328)

Revised: 12/2020

Document Id: b7889d9c-192e-ab4e-e053-2a95a90ab3bf

Set id: 6620d022-098b-1255-e053-2a91aa0ae5d2

Version: 4

Effective Time: 20201228

CMC Group, Inc.

Kit Care4 Bus & Classroom Yellow

First Aid Antibiotic Ointment, 0.9g (50814-007-01) Drug Facts

Active ingredients (in each gram)

Purpose

Use

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

First Aid Antiseptic Pain Relieving Cream, 0.9g (50814-009-01) Drug Facts

Active ingredients

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

Directions

﻿Other information

Inactive ingredients

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

Active ingredient:

Purpose

Use:

Warnings:

Do not use:

Stop use

Keep out of reach of children.

Directions:

Other information

Inactive ingredient:

Antiseptic Towelette (50814-002-01)DRUG FACTS

Active Ingredient:

Purpose:

Use:

Warnings:

Keep out of reach of children.

Do not use:

Directions:

Inactive ingredient:

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

Active Ingredient:

Purpose

Use:

Warnings:

Do not use:

Keep out of reach of children.

Inactive Ingredients:

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

First Aid Antibiotic Ointment, 0.9g (50814-007-01)
Drug Facts

First Aid Antiseptic Pain Relieving Cream, 0.9g (50814-009-01)
Drug Facts

Other information

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

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