4270 FIRST AID KIT kit 4401 FIRST AID KIT kit

4401 First Aid Kit by

Drug Labeling and Warnings

4401 First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Ammonia Inhalent Active ingredient (in each ampule)

Ammonia 15%

Ammonia Inhalent Purpose

Respiratory stimulant

Ammonia Inhalent Uses

• to prevent or treat fainting

Ammonia Inhalent Warnings

For external use only

Do not use

• if you have breathing problems such as asthma or emphysema

Stop use and ask a doctor if

• condition persists

Keep out of reach of children

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

Ammonia Inhalent Directions

• hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
• hold near nostrils for inhalation of volatile vapor

Ammonia Inhalent Other information

• store at room temperature away from light

Ammonia Inhalent Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Ammonia Inhalent Questions

1-800-430-5490

PVP Active Ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

PVP Purpose

First aid antiseptic

PVP Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

PVP Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body
• on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

• deep or puncture wounds,
• animal bites
• serious burns

When using this product

• do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

• conditions persists or gets worse
• irritation and redness develops

Keep out of reach of children.

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

PVP Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

• clean affected area
• apply to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard swab after single use

PVP Other informatiion

• store at room temperature away from light
• keep from freezing or excessive heat
• do not use if package is torn or open

PVP Inactive ingredient

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

PVP Questions

1-800-430-5490

Sting Relief Active ingredient (in each wipe)

Ethyl alcohol 50.0% Lidocaine HCl 2.0%

Sting Relief Purpose

Antiseptic

Topical pain relief

Sting Relief Uses

• prevent infection in minor scrapes, and temporary relief of itching of insect bites

Sting Relief Warnings

For external use only
Flammable, keep away from open fire or flame

Do not use

• over large areas of the body
• in eyes
• over raw or blistered areas

Stop use and ask a doctor

• if conditions worsen or 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.

Stig Relief Directions

adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
children under 2 years of age: consult a doctor.

Sting Relief Inactive ingredients

benzalkonium chloride, menthol, and purified water

Questions or Comments?

1-800-430-5490

4270 SF00001090 Kit Contents

1 1 X 3 PLASTIC 50/BOX

1 WOVEN 2" X 3" 25/BOX

1 KNUCKLE BAND 8 PER

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 INSTANT COLD PACK 4" X 6"

1 FINGERTIP BANDAGE, 10 PER

1 PVP IODINE WIPES 10 PER

2 ADHES TAPE W/P 1"X 2 1/2 YD

2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ

1 FIRST AID GUIDE ASHI

1 GZE PADS STERILE 3"X 3" 10'S

1 CPR FILTERSHIELD 77-100

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 180 EMPTY BLANK NO LOGO

1 POCKET INSERT RED #180 KIT 4R

2 BANDAGE COMP 4" W/TELFA PAD 1

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

3 PR LRG NITRILE GLVES ZIP BAG

1 WATER-JEL BURN DRESSING 4 X 4

1 NOX A STING WIPES 10

4401 SF00001103 kit contents

1 1 X 3 PLASTIC 50/BOX

1 WOVEN 2" X 3" 25/BOX

1 KNUCKLE BAND 8 PER

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 INSTANT COLD PACK 4" X 6"

1 FINGERTIP BANDAGE, 10 PER

1 PVP IODINE WIPES 10 PER

2 ADHES TAPE W/P 1"X 2 1/2 YD

2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ

1 FIRST AID GUIDE ASHI

1 GZE PADS STERILE 3"X 3" 10'S

1 CPR FILTERSHIELD 77-100

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

2 BANDAGE COMP 4" W/TELFA PAD 1

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

3 PR LRG NITRILE GLVES ZIP BAG

1 WATER-JEL BURN DRESSING 4 X 4

1 POLYBAG 14" X 20" '3 MIL'

1 STING relief WIPES 10

Ammonia Inahalent Principal Display Panel

PVP Principal Display Panel

Sting Relief Principal Display Panel

4270 Kit Label SF00001090

4401 Kit Label SF00001103

INGREDIENTS AND APPEARANCE

4270 FIRST AID KIT 
4270 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4270

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4270-01	1 in 1 KIT; Type 0: Not a Combination Product	03/14/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 AMPULE	3 mL
Part 2	10 POUCH	3 mL
Part 3	10 POUCH	4 mL

Part 1 of 3

AMMONIA INHALENT 
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC: 0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/18/2018

Part 2 of 3

PVP IODINE WIPE 
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC: 0498-0121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0121-00	0.3 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
unapproved drug other		09/18/2018

Part 3 of 3

STING RELIEF PAD 
ethyl alcohol, lidocaine swab

Product Information
Item Code (Source)	NDC: 0498-0733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0733-00	0.4 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	03/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/14/2019

4401 FIRST AID KIT 
4401 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4401

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4401-01	1 in 1 KIT; Type 0: Not a Combination Product	03/14/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 AMPULE	3 mL
Part 2	10 POUCH	3 mL
Part 3	10 POUCH	4 mL

Part 1 of 3

AMMONIA INHALENT 
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC: 0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/18/2018

Part 2 of 3

PVP IODINE WIPE 
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC: 0498-0121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0121-00	0.3 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
unapproved drug other		09/18/2018

Part 3 of 3

STING RELIEF PAD 
ethyl alcohol, lidocaine swab

Product Information
Item Code (Source)	NDC: 0498-0733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0733-00	0.4 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	03/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/14/2019

Labeler - Honeywell Safety Products USA, INC (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
James Alexander		040756421	manufacture(0498-3334)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, INC		079287321	pack(0498-4270, 0498-4401)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical		532775194	manufacture(0498-0121)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc		874965262	manufacture(0498-0733)