4133 First Aid Kit by Honeywell Safety Products USA, INC 4133 FIRST AID KIT kit

4133 First Aid Kit by

Drug Labeling and Warnings

4133 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]

Sting Relief Active ingredient

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

Sting 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

Sting relief Questions or Comments

1-800-430-5490

Eyesaline Active ingredient

Sterile Water 99%

Eyesaline Purpose

Eyewash

Eyesaline Uses

• for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyesaline Warnings

For external use only-

Obtain immediate medical treatment for all open wounds in or near eyes.

To avoid contamination, do not touch tip of container to any surface.

Do not reuse. Once opened, discard.

Do not use

• if solution changes color or becomes cloudy
• if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

• you experience eye pain
• changes in vision
• continued redness or 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.

Eyesaline Directions

• remove contacts before using
• twist top to remove
• flush the affected area as needed
• control rate of flow by pressure on the bottle
• if necessary, continue flushing with emergency eyewash or shower

Eyesaline Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Ammonia Inhalent Active ingredient

Ammonia 15%

Ammonia Inhalent Purpose

Respiratory stimulant

Ammonia Inhalent Uses

• to prevent or tret 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 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 or Comments

1-800-430-5490

Burn Jel Active ingredient

Lidocaine HCl 2.0%

Burn Jel Purpose

External analgesic

Burn Jel Uses

• temporarily relieves pain due to minor burns

Burn Jel Warnings

For external use only

Do not use

• on large areas of the body, particularly over raw surfaces or blistered areas

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• the condition gets worse
• symptoms persist for more than 7 days
• condition clears up and recurs within a few days

Keep out of reach of children

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

Burn Jel Directions

• adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor
• you may report a serious reaction to this product to 800-430-5490

Burn Jel Other information

• store at room temperature
• do not use if opened or torn

Burn Jel Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water ...

Burn Jel Questions

1-800-430-5490

Povidone Iodine Swab Active ingredient

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

Povidone Iodine Swab Purpose

First aid antiseptic

Povidone Iodine Swab Uses

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

Povidone Iodine Swab Warnings

For external use only

Do not use

• 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

Povidone Iodine Swab 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

Povidone Iodine Swab Other information

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

Povidone Iodine Swab Inactive ingredients

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

Povidone Iodine Swab Questions and comments

1-800-430-5490

Alcohol Wipe Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe Purpose

First aid antiseptic

Alcohol Wipe Uses

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

Alcohol Wipe Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burn

When using this product

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

Stop use and consult a doctor

• if condition persists or gets worse

Keep out of reach of children

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

Alcohol Wipe Directions

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

Alcohol Wipe Other information

store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)

Alcohol Wipe Inactive ingredient

water

Alcohol Wipe Questions

1-800-430-5490

4133 SF00004171 Kit Contents

1 KNUCKLE BAND 8 PER

1 AMMONIA INHALANTS 10 PER

1 GAUZE BANDAGE, 4" X 6 YD

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 3" X 3", 4 PER

1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

2 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 1 OZ EYE WASH W/PADS & STRIPS

1 BURN JEL 1/8 OZ, 6 PER

1 PVP IODINE WIPES 10 PER

1 STING RELIEF WIPES 10 PER BOX

1 MICROSHIELD W/VNL GLV/ALCL

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 16 UN (VERTICAL)

1 LABL INSTR FA REV A

Sting Relief Principal Display Panel

Eyesaline Principal Display Panel

Ammonia inhalent Principal Display Panel

Burn Jel Principal Display Panel

Povidone Iodine Swab Principal Display Panel

Alcohol Wipe Principal Display Panel

4133 Kit Label SF00004171

INGREDIENTS AND APPEARANCE

4133 FIRST AID KIT 
4133 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4133

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4133-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 POUCH	4 mL
Part 2	1 BOTTLE	30 mL
Part 3	10 AMPULE	3 mL
Part 4	4 POUCH	1.6 mL
Part 5	10 POUCH	3 mL
Part 6	6 PACKET	21 g

Part 1 of 6

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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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	12/23/2017

Part 2 of 6

EYESALINE EMERGENCY EYEWASH 
purified water liquid

Product Information
Item Code (Source)	NDC: 0498-0100
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/18/2018

Part 3 of 6

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 4 of 6

ALCOHOL WIPE 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 0498-0143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0143-04	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	part333A	09/18/2018

Part 5 of 6

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 6 of 6

BURN JEL 
gel for burns gel

Product Information
Item Code (Source)	NDC: 0498-0203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0203-00	3.5 g in 1 PACKET; 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	09/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2018

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(0498-4133)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0203)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc.		167518617	manufacture(0498-0100)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical		421317073	manufacture(0498-0143)

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)