4042,4050 First Aid Kit (PVP, First Aid Burn Cr, Triple- Z019708-0005L, 01709-0005L)

Drug Labeling and Warnings

Drug Details [pdf]

4050 FIRST AID KIT- 4050 first aid kit 
4042 FIRST AID KIT- 4042 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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4042,4050 First Aid Kit (PVP, First Aid Burn Cr, Triple- Z019708-0005L, 01709-0005L)

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

Triple
Active ingredients

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Triple
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple
Uses

first aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Triple
Warnings

For external use only

Allergy alert: do not use if you are allergic to any of the ingredients

Triple
Do not use

  • in the eyes
  • over large areas of the body

Triple
Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Triple
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

Triple
Keep out of reach of children

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

Triple
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

Triple
Other information

  • store at 15 o to 25 o C (59 o to 77 oF)
  • tamper evident sealed packets
  • do not use if packet is torn or opened

Triple
Inactive ingredients

petrolatum

Triple
Questions

1-800-430-5490

4042
Z019708-0005L 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"

4050
019709-0005L Kit Contents

TRIPLE ANTIBIOTIC

FIRST AID BURN CREAM

TRIANGULAR BDG, NON-STERILE

GAUZE PADS, 3" X 3", 4 PER

ADH TAPE, .5" X 2.5 YD, 2 PER

GAUZE COMP, 1 SQ YARD, 1 PER

INSTANT COLD PACK 4" X 6"

ADHESIVE BDG,PLSTIC,1"X3"16PER

PVP IODINE WIPES

NITRILE GLOVES 2PR BBP

FIRST AID GUIDE ASHI

SCISSOR BDGE 4" RED PLS HDL

Honeywell PVP Wipes

Honeywell PVP wipe

Burn Cream
Principal Display Panel

Burn Cream

Triple
Principal Display Panel

Triple Antibiotic

4042 Kit Label
Z019708-0005L

4042 Kit label

4050 Kit label
019709-005L

4050 Kit Label

4050 FIRST AID KIT 
4050 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4050
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4050-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 0.3 mL
Part 21 PACKET 0.9 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
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC: 0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/201810/18/2019
4042 FIRST AID KIT 
4042 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4042
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4042-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 0.3 mL
Part 21 PACKET 0.9 g
Part 310 PACKET 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
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC: 0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
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(0498-4042, 0498-4050)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0903, 0498-0750)

Revised: 10/2019