KIT LARGE OFFICE FIRST AID- benzalkonium chloride, water, alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, isopropyl alcohol, benzalkonium chloride, lidocaine hydrochloride
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 Large Office First Aid

Antiseptic Towelette 10 count 49687-0011-0
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.

Drug Facts
Eyewash 1 oz 49687-0020-0

Active ingredient

Purified Water 99.1%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep out of reach of children.

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

Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Inactive ingredients

Benzalkonium chloride, sodium chloride

Hand Sanitizer 49687-0015-0
Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin
Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame

For external use only.

Do not use

in the eyes.

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Antibiotic Application (49687-0013-0)
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

Alcohol Cleansing Pad 20 count 49687-0012-0
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.

Burn Treatment 10 count 49687-0014-0
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 reah 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

Package Labeling:

Kit

Package Labeling:

Label1

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Label6

KIT LARGE OFFICE FIRST AID
benzalkonium chloride, water, alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, isopropyl alcohol, benzalkonium chloride, lidocaine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0027

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49687-0027-0	1 in 1 KIT	02/13/2018	10/31/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	40 POUCH	18 g
Part 2	1 TUBE	30 mL
Part 3	6 PACKAGE	5.4 g
Part 4	10 PACKAGE	9 g
Part 5	20 POUCH	18 g
Part 6	10 POUCH	9 g

Part 1 of 6

ANTISEPTIC TOWELETTES
benzalkonium chloride cloth

Product Information
Item Code (Source)	NDC:49687-0011
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	NDC:49687-0011-0	20 in 1 KIT
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	part333A	02/13/2018	10/31/2020

Part 2 of 6

EYE WASH
water solution

Product Information
Item Code (Source)	NDC:49687-0010
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	991 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description
Packaging
1	NDC:49687-0010-0	1 in 1 KIT
1		30 mL in 1 TUBE; 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	part349	02/13/2018	10/31/2020

Part 3 of 6

HAND SANITIZER
alcohol gel

Product Information
Item Code (Source)	NDC:49687-0015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description
Packaging
1	NDC:49687-0015-1	6 in 1 BOX
1		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	part333E	02/13/2018	10/31/2020

Part 4 of 6

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

Product Information
Item Code (Source)	NDC:49687-0013
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:49687-0013-0	10 in 1 KIT
1		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 final	part333B	02/13/2018	10/31/2020

Part 5 of 6

ALCOHOL CLEANSING
isopropyl alcohol cloth

Product Information
Item Code (Source)	NDC:49687-0012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 g in 100 g

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

#	Item Code	Package Description
Packaging
1	NDC:49687-0012-0	20 in 1 KIT
1		0.9 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	part333A	02/13/2018	10/31/2020

Part 6 of 6

BURN TREATMENT
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:49687-0014
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
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

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

#	Item Code	Package Description
Packaging
1	NDC:49687-0014-0	10 in 1 KIT
1		0.9 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	part333A	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. (117201448)

Name	Address	ID/FEI	Business Operations
Establishment
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture(49687-0027, 49687-0011, 49687-0010, 49687-0015, 49687-0013, 49687-0012, 49687-0014)

Revised: 1/2021

Document Id: b6962318-7aae-0675-e053-2a95a90a9fe5

Set id: 6620d157-cf21-80d3-e053-2991aa0ad0c4

Version: 4

Effective Time: 20210107

CMC Group, Inc.

Kit Large Office First Aid

Antiseptic Towelette 10 count 49687-0011-0 DRUG FACTS

Active Ingredient:

Purpose:

Use:

Warnings:

Keep out of reach of children.

Do not use:

Directions:

Inactive ingredient:

Drug Facts Eyewash 1 oz 49687-0020-0

Active ingredient

Purpose

Use

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Hand Sanitizer 49687-0015-0 Drug Facts

Active ingredient

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach children.

Directions

Other information

Inactive ingredients

Antibiotic Application (49687-0013-0) 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

Alcohol Cleansing Pad 20 count 49687-0012-0 DRUG FACTS

Active Ingredient:

Purpose:

Use:

Warnings:

Do not use:

Stop use

Keep out of reach of children.

Directions:

Other information:

Inactive ingredient:

Burn Treatment 10 count 49687-0014-0 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 reah of children.

Directions

Other information

Inactive ingredients

Package Labeling:

Package Labeling:

Package Labeling:

Package Labeling:

Package Labeling:

Package Labeling:

Package Labeling:

Antiseptic Towelette 10 count 49687-0011-0
DRUG FACTS

Drug Facts
Eyewash 1 oz 49687-0020-0

Hand Sanitizer 49687-0015-0
Drug Facts

Antibiotic Application (49687-0013-0)
Drug Facts

Other information

Alcohol Cleansing Pad 20 count 49687-0012-0
DRUG FACTS

Burn Treatment 10 count 49687-0014-0
Drug Facts