4270 FIRST AID KIT kit 4401 FIRST AID KIT kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
Respiratory stimulant - to prevent or treat fainting First aid antiseptic - first aid to help prevent the risk of infection in minor cuts, scrapes, and burns Antiseptic Topical pain relief - prevent infection in minor scrapes, and temporary relief of itching of insect bites
Authorization status:
unapproved drug other
Authorization number:
0498-0121-00, 0498-0733-00, 0498-3334-00, 0498-4270-01, 0498-4401-01

4270 FIRST AID KIT- 4270 first aid kit

4401 FIRST AID KIT- 4401 first aid kit

Honeywell Safety Products USA, INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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4270, 4401 First Aid Kit (Amm Inh, PVP wipes, sting relief- SF00001090, SF00001103)

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

4270 FIRST AID KIT

4 270 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4270

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4270 -0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

10 AMPULE

3 mL

Pa rt 2

10 POUCH

3 mL

Pa rt 3

10 POUCH

4 mL

Part 1 of 3

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 2 of 3

PVP IODINE WIPE

povidone-iodine 10% swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 121

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 121-0 0

0 .3 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 3 of 3

STING RELIEF PAD

ethyl alcohol, lidocaine swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 733

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

20 mg

in 1 mL

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .5 mL

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MENTHO L (UNII: L7T10 EIP3A)

WATER (UNII: 0 59 QF0 KO0 R)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 733-0 0

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 3/14/20 19

4401 FIRST AID KIT

4 4 01 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -440 1

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -440 1-0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

10 AMPULE

3 mL

Pa rt 1

10 AMPULE

3 mL

Pa rt 2

10 POUCH

3 mL

Pa rt 3

10 POUCH

4 mL

Part 1 of 3

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 2 of 3

PVP IODINE WIPE

povidone-iodine 10% swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 121

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 121-0 0

0 .3 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 3 of 3

STING RELIEF PAD

ethyl alcohol, lidocaine swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 733

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

20 mg

in 1 mL

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .5 mL

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MENTHO L (UNII: L7T10 EIP3A)

WATER (UNII: 0 59 QF0 KO0 R)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

Honeywell Safety Products USA, INC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 733-0 0

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 3/14/20 19

Labeler -

Honeywell Safety Products USA, INC (079287321)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

James Alexander

0 40 756 421

ma nufa c ture (0 49 8 -3334)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, INC

0 79 28 7321

pack(0 49 8 -4270 , 0 49 8 -440 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sio n Bio text Medical

53277519 4

ma nufa c ture (0 49 8 -0 121)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Safetec o f America Inc

8 749 6 526 2

ma nufa c ture (0 49 8 -0 733)

Revised: 9/2019

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