Label: 4064 FIRST AID KIT kit
4065 FIRST AID KIT kit
4066 FIRST AID KIT kit
4067 FIRST AID KIT kit

  • NDC Code(s): 0498-0121-00, 0498-0121-34, 0498-0750-35, 0498-4064-01, view more
    0498-4065-01, 0498-4066-01, 0498-4067-01
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated October 18, 2019

If you are a consumer or patient please visit this version.

  • 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

  • 4064 Z019737-0024L Kit Contents

    TRIPLE ANTIBIOTIC 10 PER

    FIRST AID BURN CREAM 6 PER

    TRIANGULAR BDG, NON-STERILE

    WIRE SPLINT 1 PER

    BANDAGE COMP, 2" OFFSET, 4 PER

    BANDAGE COMP, 4" OFFSET, 1 PER

    ADHESIVE BDG,PLSTIC,1"X3"16PER

    PVP IODINE WIPES 10 PER

    NITRILE GLOVES 2PR BBP

    FIRST AID GUIDE ASHI

  • 4065 019737-0024L Kit Contents

    TRIPLE ANTIBIOTIC 10 PER

    FIRST AID BURN CREAM 6 PER

    TRIANGULAR BDG, NON-STERILE

    WIRE SPLINT 1 PER

    GAUZE PADS, 3" X 3", 4 PER

    BANDAGE COMP, 2" OFFSET, 4 PER

    BANDAGE COMP, 4" OFFSET, 1 PER

    ADHESIVE BDG,PLSTIC,1"X3"16PER

    PVP IODINE WIPES 10 PER

    ADHESIVE TAPE W/P 1/2"X 5 YD

    1 PR LRG NITRILE GLVES ZIP BAG

  • 4066 Z019839 Kit Contents

    TRIPLE ANTIBIOTIC 10 PER

    FIRST AID BURN CREAM 6 PER

    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 10 PER

    NITRILE GLOVES 2PR BBP

    FIRST AID GUIDE ASHI

    SCISSOR BDGE 4" RED PLS HDL

  • 4067 019708-0005L Kit Contents

    TRIPLE ANTIBIOTIC 10 PER

    FIRST AID BURN CREAM 6 PER

    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 10 PER

    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

  • 4064 Kit Label Z019737-0024L

    4064 kit

  • 4065 Kit Label 019737-0024l

    4065 kit

  • 4066 Kit label Z019839

    4066 kit

  • 4067 Kit Label 019708-0005L

    4067 Kit

  • INGREDIENTS AND APPEARANCE
    4064 FIRST AID KIT 
    4064 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4064
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4064-011 in 1 KIT11/21/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 POUCH 3 mL
    Part 26 PACKET 5.4 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
    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
    4065 FIRST AID KIT 
    4065 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4065
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4065-011 in 1 KIT11/21/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 POUCH 3 mL
    Part 26 PACKET 5.4 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
    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 other11/21/2018
    4066 FIRST AID KIT 
    4066 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4066
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4066-011 in 1 KIT11/21/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 POUCH 3 mL
    Part 26 PACKET 5.4 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
    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 other11/21/2018
    4067 FIRST AID KIT 
    4067 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4067
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4067-011 in 1 KIT11/21/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 POUCH 3 mL
    Part 26 PACKET 5.4 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
    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 other11/21/2018
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-4064, 0498-4065, 0498-4066, 0498-4067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903, 0498-0750)