4044, 4045 First Aid Kit (PVP, First Aid Burn Cr- Z019733-0019L, 019733-0020L)

Drug Labeling and Warnings

Drug Details [pdf]

4044 FIRST AID KIT- 4044 first aid kit 
4045 FIRST AID KIT- 4045 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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4044, 4045 First Aid Kit (PVP, First Aid Burn Cr- Z019733-0019L, 019733-0020L)

PVP Wipes
Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

PVP Wipes
Purpose

First aid antiseptic

PVP Wipes
Uses

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

PVP Wipes
Warnings

For external use only.

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens or persists for more than 72 hours
  • irritation and redness develops

Keep out of reach of children.

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

PVP Wipes
Directions

  • clean the affected area
  • apply1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
  • discard wipe after single use

PVP Wipes
Other information

  • do not use on individuals who are allergic or sensitive to iodine
  • store at controlled temperature 59-86ºF (15-30ºC)
  • do not use if pouch is open or torn

PVP Wipes
Inactive ingredients

nonoxynol 9, water

PVP Wipes
Questions

800-430-5490

Burn Cream
Active ingredient

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Burn Cream
Purpose

First aid antiseptic

External analgesic

Burn Cream
Uses

  • prevent skin infection
  • for temporary relief of pain associated with miinor burns

Burn Cream
Warnings

For external use only

Do not use

  • in or near the eyes
  • if you are allergic to any of the ingredients
  • in large areas of the body particularly over raw surfaces or blistered areas
  • for more than 10 days

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of chidren

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

Burn Cream
Directions

  • adults and children 2 years of age and older:
  • clean the affected area
  • apply a small amount of this product (equal to the area of the tip of finger) onto the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

Burn Cream
Other information

  • tamper evident sealed packets
  • do not use if packet is opened or torn

Burn Cream
Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

Burn Cream
Questions

1-800-430-5490

Neomycin
Active ingredient

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

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

first aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Neomycin
Warnings

For external use only

Neomycin
Do not use

  • in the eyes
  • over large areas of the body

Neomycin
Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Neomycin
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

Neomycin
Keep out of reach of children

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

Neomycin
Directions

  • clean the affected area
  • apply a small amount of the 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

Neomycin
Other information

Store at 15 o to 25 o C (59 o to 77 oF)

Neomycin
Inactive ingredients

petrolatum

Neomycin
Questions

1-800-430-5490

4044
Z019733-0020L Kit Contents

FIRST AID GUIDE ASHI

GAUZE CLEAN-WRAP BDGE N/S 2"

PVP PREP PADS MEDIUM 100/BX

SCISSOR BDGE 4" RED PLS HDL

FIRST AID CREAM 1.0GR PKT EACH

TAPE ADHESIVE 1/2 X 2.5 125133

POUCH NEOMYCIN ANTIBIOTIC .9 G

ADH BNDG PLASTIC EX-LG 4"X 2"

GAUZE PADS 3"X3" 12PLY

PLASTIC BANDAGE 1" X 3"

4045
019733-0020L Kit Contents

FIRST AID GUIDE ASHI

GAUZE CLEAN-WRAP BDGE N/S 2"

PVP PREP PADS MEDIUM 100/BX

SCISSOR BDGE 4" RED PLS HDL

FIRST AID CREAM 1.0GR PKT EACH

TAPE ADHESIVE 1/2 X 2.5 125133

POUCH NEOMYCIN ANTIBIOTIC .9 G

ADH BNDG PLASTIC EX-LG 4"X 2"

GAUZE PADS 3"X3" 12PLY

PLASTIC BANDAGE 1" X 3"

Honeywell PVP Wipes

Honeywell PVP wipe

Burn Cream
Principal Display Panel

Burn Cream

Neomycin
Principal Display Panel

Neomycin

4044 Kit Label
Z019733-0019L

4044 kit label

4045 Kit Label
019733-0020L

4045 kit label

4044 FIRST AID KIT 
4044 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4044
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4044-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 POUCH 1.8 mL
Part 24 PACKET 3.6 g
Part 31 PACKET 0.9 g
Part 1 of 3
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC: 0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0121-3410 in 1 CARTON
1NDC: 0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 2 of 3
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC: 0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 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 finalpart333A12/20/2017
Part 3 of 3
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/201810/18/2019
4045 FIRST AID KIT 
4045 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4045
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4045-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 POUCH 1.8 mL
Part 24 PACKET 3.6 g
Part 34 PACKET 3.6 g
Part 1 of 3
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC: 0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0121-3410 in 1 CARTON
1NDC: 0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 2 of 3
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC: 0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 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 finalpart333A12/20/2017
Part 3 of 3
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/201810/18/2019
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4044, 0498-4045)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0903, 0498-0730)

Revised: 10/2019