Label: 4241 FIRST AID KIT kit
4125 FIRST AID KIT kit

  • NDC Code(s): 0498-0021-40, 0498-0031-40, 0498-0100-02, 0498-0143-04, view more
    0498-0501-00, 0498-0750-36, 0498-3334-00, 0498-4125-01, 0498-4241-01
  • 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 May 5, 2019

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

  • Eyewash Active ingredient

    Sterile Water 99%

  • Eyewash Purpose

    Eyewash

  • Eyewash Uses

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

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Eyewash Questions

    1-800-430-5490

  • Ammonia Active ingredient

    Ammonia 15%

  • Ammonia Purpose

    Respiratory stimulant

  • Ammonia Uses

    • to prevent or treat fainting
  • Ammonia 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 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 Other information

    • store at room temperature away from light
  • Ammonia Inactive ingredient

    alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

  • Ammonia Questions or Comments?

    1-800-430-5490

  • Water Soluble 1st Aid Spray Active ingredient

    Benzethonium chloride 0.2% w/w - Benzocaine 10% w/w

  • Water Soluble 1st Aid Spray Purpose

    Topical antiseptic

    Topical anesthetic

  • Water Soluble 1st Aid Spray Uses

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

    • minor cuts and scrapes
    • insect bites
    • minor skin irritations

  • Water Soluble 1st Aid Spray Warnings

    For external use only

    Flammable

    • keep away from fire or flame
    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperature above 120 0 F

    Do not use

    • in the eyes or other mucous membranes
    • in cases of serious burns
    • in case of deep orpuncture wounds
    • for a 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 occurs again within a few days
    • redness, swelling, or irritation occurs

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Water Soluble 1st Aid Spray Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage. If bandaged, let dry first
    • for adult institutional use only
    • not intended for use on children
  • Water Soluble 1st Aid pray Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal
  • Water Soluble 1st Aid pray Inactive ingredients


    dipropylene glycol, isobutane, N-butane, propane

  • Burn Relief Water Soluble Active ingredients

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

  • Burn Relief Water Soluble Purpose


    Topical antiseptic

    Topical anesthetic

    Topical anesthetic

  • Burn Relief Water Soluble Uses

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

    • minor cuts and scrapes
    • burns
    • sunburn
    • insect bites
    • minor skin irritations
  • Burn Relief Water Soluble Warnings

    For external use only

    Flammable keep away from fire or flame

    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperatures above 120 0 F

    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 Relief Water Soluble Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
  • Burn Relief Water Soluble Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
  • Burn Relief Water Soluble Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

  • Triple Active ingredients

    Bacitracin zinc 400 units

    Neomycin 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

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • a deep or puncture wounds
    • animal bites
    • serious burns


    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 the 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 0 to 25 0 C (59 0 to 77 0 F)
    • tamper evident sealed packets
    • do not use if packet is torn or opened
  • Triple Inactive ingredient

    petrolatum

  • Alcohol Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Purpose

    First aid antiseptic

  • Alcohol Uses

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

    For external use only

    Flammable, keep away from fire or flame.

    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

    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 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 Other information

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

  • Alcohol Inactive ingredient

    water

  • BZK Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

    Antiseptic cleansing of face, hands, and body without soap and water

  • BZK Warnings

    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • if irritation, redness or other symptoms develop
    • 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.

  • BZK Directions

    • tear open packet and use as a washcloth
  • BZK Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactive ingredient

    water

  • BZK Questions

    1-800-430-5490

  • 4125 SF00004255 kit contents

    1 3/4 X 3 PLAS 100/BOX

    1 1X3 PLASTIC 100/BOX

    1 FNGERTP WOVEN REG 40/BOX

    1 WOVEN 2" X 3" 25/BOX

    1 1X3 WOVEN SING 50/BOX

    1 SWIFT KNUCKLE 40/BX

    1 AMMONIA INHALANTS 10 PER

    1 INSTANT COLD PACK 4" X 6"

    1 ELASTIC TAPE 1" X 5YD

    1 O/H TAPE ADHESIVE TRI-CUT

    1 FIRST AID GUIDE ASHI

    6 GAUZE CLEAN-WRAP BDGE N/S 2"

    2 BLOODSTOPPER

    1 NON ADHERENT PADS 2"X3" 50'S

    1 GZE PADS STERILE 2"X 2" 25'S

    1 GZE PADS STERILE 4"X 4" 25'S

    1 CO-FLEX BANDAGE 2"X 5YDS TAN

    1 COTTON TIPS 100 PER VIAL

    1 ANTISEPTIC WIPES BZK CHL 20'S

    1 FIRST AID SPRAY AEROSOL 3 OZ

    1 ALCOHOL WIPES 50'S

    1 BURN SPRAY 3 OZ

    1 TRIPLE BIOTIC .5 GRAM PKT 20

    1 QUICK RELIEF 1 PACK OF 2/BOX

    1 COLD PACK 5"X9" BOXED

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 SPLINTER FORCEP 4 1/2"

    1 SCISSOR LISTER BDG S/S 5 1/2"

    1 400 EMPTY KIT BLANK

    1 POCKET INSERT RED #400 KIT 5R

    1 TONGUE BLADES SR WRAPPED 6'S

    1 ISO-SHIELD CPR ADULT/CHLD 1BG

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 TRI BNDG NON WOVEN 40"X40"X56"

    1 RESCUE BLANKET 1EA

    1 RED BIO BAGS 2/BX

    6 NITRILE GLOVES 1 PR

  • 4241 68400LNT KIT CONTENTS

    1 3/4 X 3 PLAS 100/BOX

    1 1X3 PLASTIC 100/BOX

    1 WOVEN 2" X 3" 25/BOX

    1 FINGERTIP "T" WOVEN 40/BOX

    1 1X3 WOVEN SING 50/BOX

    1 SWIFT KNUCKLE 40/BX

    1 AMMONIA INHALANTS 10 PER

    1 ELASTIC TAPE 1" X 5YD

    1 FORCEPS POINTED METAL

    1 O/H TAPE ADHESIVE TRI-CUT

    1 FIRST AID GUIDE ASHI

    6 GAUZE CLEAN-WRAP BDGE N/S 2"

    2 BLOODSTOPPER

    1 NON ADHERENT PADS 2"X3" 50'S

    2 GZE PADS STERILE 2"X 2" 25'S

    1 GZE PADS STERILE 4"X 4" 25'S

    1 CO-FLEX BANDAGE 2"X 5YDS TAN

    1 COTTON TIPS 100 PER VIAL

    1 ANTISEPTIC WIPES BZK CHL 20'S

    1 FIRST AID SPRAY AEROSOL 3 OZ

    1 ALCOHOL WIPES 50'S

    1 BURN SPRAY 3 OZ

    1 TRIPLE BIOTIC .5 GRAM PKT 20

    1 COLD PACK 5"X9" BOXED

    1 4OZ BFS EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 400 EMPTY KIT BLANK

    1 POCKET INSERT RED #400 KIT 5R

    1 TONGUE BLADES SR WRAPPED 6'S

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    2 ADHES TAPE EYE STRIPS 2'S

    2 TRI BNDG NON WOVEN 40"X40"X56"

    1 RED BIO BAGS 2/BX

  • Eyewash Principal Display Panel

    Eyesaline

  • Ammonia Principal Display Panel

    Ammonia Inhalant

  • Water Soluble 1st Aid Spray Principal Display Panel

    Water Soluble 1st Aid Spray

  • Burn Relief Water Soluble Principal Display Panel

    Burn Spray

  • Triple Principal Display Panel

    Triple Antibiotic

  • Alcohol Principal Display Panel

    Alcohol Preps

  • BZK Principal Display Panel

    Antiseptic Wipe

  • 4125 Kit Label SF00004255

    4125 label

  • 4241 Kit Label 68400LNT

    4241 label

  • INGREDIENTS AND APPEARANCE
    4241 FIRST AID KIT 
    4241 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4241
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4241-011 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 AMPULE 3 mL
    Part 31 CAN 85 g
    Part 41 CAN 85 g
    Part 520 PACKET 10 g
    Part 650 POUCH 20 mL
    Part 720 PACKET 28 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 PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    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
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source)NDC:0498-3334
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 3 of 7
    FIRST AID ANTISEPTIC WATER SOLUBLE 
    benzethonium chloride, benzocaine spray
    Product Information
    Item Code (Source)NDC:0498-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0031-4085 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/19/2018
    Part 4 of 7
    BURN WATER SOLUBLE 
    benzocaine, benzethonium chloride, menthol spray
    Product Information
    Item Code (Source)NDC:0498-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0021-4085 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/12/2018
    Part 5 of 7
    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
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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:0498-0750-360.5 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
    Part 6 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 7 of 7
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    4125 FIRST AID KIT 
    4125 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4125
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4125-011 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 AMPULE 3 mL
    Part 31 CAN 85 g
    Part 41 CAN 85 g
    Part 520 PACKET 10 g
    Part 650 POUCH 20 mL
    Part 720 PACKET 28 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 PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    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
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source)NDC:0498-3334
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 3 of 7
    FIRST AID ANTISEPTIC WATER SOLUBLE 
    benzethonium chloride, benzocaine spray
    Product Information
    Item Code (Source)NDC:0498-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0031-4085 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/19/2018
    Part 4 of 7
    BURN WATER SOLUBLE 
    benzocaine, benzethonium chloride, menthol spray
    Product Information
    Item Code (Source)NDC:0498-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0021-4085 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/12/2018
    Part 5 of 7
    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
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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:0498-0750-360.5 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
    Part 6 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 7 of 7
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/22/2017
    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
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4241, 0498-4125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0031, 0498-0021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0143, 0498-0501)