Drug Facts - Eye Wash (49687-0010-0)

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

Drug Facts - Antiseptic Towelettes (49687-0016-0)

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 - Alcohol Cleansing Pads (49687-0012-0)

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.

Drug Facts - Antibiotic Application (49687-0013-0)

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.

Inactive ingredients

Mineral oil, petrolatum, purified water

Drug Facts - Burn Treatment (49687-0014-0)

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

Drug Facts - Hand Sanitizer (49687-0015-0)

Inactive ingredients

glycerin monostearate, glycerol, purified water

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 flameFor 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

Eye Wash (49687-0010-0) Labeling:

Eye wash

Antiseptic Towelettes (49687-0016-0) Labeling:

Towelettes

Alcohol Cleansing Pads (49687-0012-0) Labeling:

Alcohol cleansing

Antibiotic Application (49687-0013-0) Labeling:

Antibiotic Application

Burn Treatment (49687-0014-0) Labeling:

Burn treatment

Hand Sanitizer (49687-0015-0) Labeling:

Hand sanitizer

Standard ANSI First Aid (49687-0020-0) Labeling:

Standard

STANDARD ANSI FIRST AID
water, benzalkonium chloride, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0020

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49687-0020-0	1 in 1 KIT	08/10/2016

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

Part 1 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:49687-0010-1	1 in 1 BOX
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 Drug	M018	08/10/2016

Part 2 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:49687-0011-1	10 in 1 BOX
1		0.9 g in 1 PATCH; 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 Drug	M003	08/10/2016

Part 3 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 Drug	M003	08/10/2016

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 Drug	M004	08/10/2016

Part 5 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 Drug	M003	08/10/2016

Part 6 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 Drug	505G(a)(3)	08/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	part333	08/10/2016

Labeler - CMC Group, Inc. (117201448)

Standard ANSI First Aid Kit

Drug Facts - Eye Wash (49687-0010-0)

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

Drug Facts - Antiseptic Towelettes (49687-0016-0)

Active Ingredient:

Purpose:

Use:

Warnings:

Keep out of reach of children.

Do not use:

Directions:

Inactive ingredient:

DRUG FACTS - Alcohol Cleansing Pads (49687-0012-0)

Active Ingredient:

Purpose:

Use:

Warnings:

Do not use:

Stop use

Keep out of reach of children.

Directions:

Other information:

Inactive ingredient:

Drug Facts - Antibiotic Application (49687-0013-0)

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

Inactive ingredients

Drug Facts - Burn Treatment (49687-0014-0)

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

Drug Facts - Hand Sanitizer (49687-0015-0)

Inactive ingredients

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

Eye Wash (49687-0010-0) Labeling:

Antiseptic Towelettes (49687-0016-0) Labeling:

Alcohol Cleansing Pads (49687-0012-0) Labeling:

Antibiotic Application (49687-0013-0) Labeling:

Burn Treatment (49687-0014-0) Labeling:

Hand Sanitizer (49687-0015-0) Labeling:

Standard ANSI First Aid (49687-0020-0) Labeling: