4360 FIRST AID KIT- 4360 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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4360 First Aid Kit (Neomycin, EW, alcohol wipes, HC cr, Burn Sray, Antiseptic Spray, Hand Sanitizer- FRKSOFTPAK-CLSB)

Eyesaline
Active ingredient

Sterile Water 99%

Eyesaline
Purpose

Eyewash

Eyesaline
Uses

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

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

Alcohol Wipe
Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe
Purpose

First aid antiseptic

Alcohol Wipe
Uses

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

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

Neomycin
Active ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

Do not use

  • in the eyes
  • over large areas of the body

Neomycin
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 burns


Stop use and ask a doctor if

  • a rash or other allergic reaction develops
  • you need to use longer than 1 week

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
  • you need to use longer than 1 week

Keep out of reach of children

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

Neomycin
Direction

Neomycin
Other information


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

Neomycin
Inactive ingredient

petrolatum

Neomycin
Questions?

1-800-430-5490

Antiseptic Spray
Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray
Purpose

First aid antiseptic

Antiseptic Spray
Uses

Antiseptic Spray
Warnings

For external use only

Do not use

  • in or near the eyes
  • over large areas of the body

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 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse

Keep out of reach of children

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

Antiseptic Spray
Directions

Antiseptic Spray
Other information

Antiseptic Spray
Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

Antiseptic Spray
Questions

1-800-430-5490

Burn Spray
Active ingredient

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray
Purpose

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray
Uses

for the temporary relief of pain and itching and helps protect against infection in:

Burn Spray
Warnings

For external use only

Flammable

Do not use

  • in or near the eyes or other mucous membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling, or irritation occurs

Keep out of the reach of children

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

Burn Spray
Directions

Burn Spray
Other information

Burn Spray
Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Hans Sanitizer
Active ingredient

Ethyl alcohol 62%

Hand Santizer
Purpose

Antiseptic handwash

Hand Sanitizer
Uses

Hand Sanitizer
Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

  • do not use in the eyes
  • discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

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

Hand Sanitizer
Directions

Hand Sanitizer
Other information

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

Hand Sanitizer
Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer
Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

Hydrocortisone
Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone
Purpose

Anti-itch cream

Hydrocortisone
Uses

Hydrocortisone
Warnings

For external use ;only

Ask a doctor before use if

  • if you are using any other hydrocortisone product

When using the product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Stop use and ask a doctor if

  • condition worsens
  • condition persists 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.

Hydrocortisone
Directions

Hydrocortisone
Other information

Hydrocortisone
Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Hydrocortisone
Questions or Comments?

1-800-430-5490

Eyesaline
Principal Display Panel

Eyesaline

Alcohol Wipe
Principal Display Panel

OH Pak Alcohol Wipe

Neomycin
Principal Display Panel

Neomycin

Antiseptic Spray
Principal Display Panel

Antiseptic Spray

Burn Spray
Principal Display Panel

Burn Spray

Hand sanitizer
Principal Display Panel

Hand Sanitizer

Hydrocortisone
Principal Display Panel

Hydrocortisone

4360 Kit Label
FRKSOFTPAK-CLSB

4360 label

4360 Kit Contnets
FRKSOFTPAK-CLSB

1 1 X 3 WOVEN 100/BOX

3 NEOMYCIN ANTIBIOTIC 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 RESCUE BLANKET 1 PER

1 GAUZE COMP, 18" X 36", 2 PER

1 BANDAGE COMP, 2" OFFSET, 4 PER

1 ALCOHOL PREP PADS 10P

1 HYDROCORTISON,1.O%,1/32 OZ,10P

1 O/H PAK,ADH BDG 2"X4", X-LG,10 PER

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

1 TAPE ADHESIVE 1"X 5 YD PLSTC

10 HAND SANITIZER 0.9G WJ BULK

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

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

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

4 PR LRG NITRILE GLVES

2 WATER-JEL BURN DRESSING 4 X 4

1 KIT BAG SOFT PACK LARGE

1 LBL CONTENTS ANSI 2015 CL B

2 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

4 WOVEN FINGERTIP BANDAGE 2"

6 WOVEN KNUCKLE BANDAGE

4360 FIRST AID KIT 
4360 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4360
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4360-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 210 POUCH 4 mL
Part 310 PACKET 9 g
Part 41 BOTTLE, SPRAY 59 mL
Part 51 BOTTLE, SPRAY 59 mL
Part 630 PACKET 27 g
Part 710 PACKAGE 9 mL
Part 1 of 7
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 2 of 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/18/2018
Part 3 of 7
HYDROCORTISONE 
anti-itch cream
Product Information
Item Code (Source)NDC:0498-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0801-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2019
Part 4 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2018
Part 5 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/18/2018
Part 6 of 7
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/31/2010
Part 7 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
Labeler - Honeywell Safety Products USA, INC (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4360)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0730, 0498-0402, 0498-0221, 59898-420, 0498-0801)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0143)

Revised: 5/2019
Document Id: 8a38e424-c021-6293-e053-2a95a90a74d8
Set id: 8a38e424-c020-6293-e053-2a95a90a74d8
Version: 1
Effective Time: 20190531
 
Honeywell Safety Products USA, INC