4190 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]

4190 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0733-00, 0498-3334-00, 0498-4190-01
Set ID 850a550b-a885-a375-e053-2991aa0a723b
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, INC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number
  • Ammonia Inhalent Active ingredient (in each ampule)

    Ammonia 15%

  • Ammonia Inhalent Purpose

    Respiratory stimulant

  • Ammonia Inhalent Uses

    • to prevent or treat fainting
  • Ammonia Inhalent 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 Inhalent 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 Inhalent Other information

    • store at room temperature away from light
  • Ammonia Inhalent Inactive ingredients

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

  • Ammonia Inhalent Questions

    1-800-430-5490

  • 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

  • PVP Active Ingredient

    Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

  • PVP Purpose

    First aid antiseptic

  • PVP Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
  • PVP Warnings


    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • on individuals who are allergic or sensitive to iodine


    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 wek unless directed by a doctor

    Stop use and ask a doctor if

    • conditions persists or gets worse
    • irritation and redness develops
  • Keep out of reach of children.

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

    Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

    • clean affected area
    • apply to affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • discard swab after single use
  • PVP Other informatiion

    • store at room temperature away from light
    • keep from freezing or excessive heat
    • do not use if package is torn or open
  • PVP Inactive ingredient

    citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

  • PVP Questions

    1-800-430-5490

  • Alcohol Active ingredient

    Isproppyl 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 and flame

  • Sting Relief Active ingredient (in each wipe)

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

  • Sting Relief Purpose


    Antiseptic

    Topical pain relief

  • Sting Relief Uses

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
  • Sting Relief Warnings

    For external use only

    Flammable, keep away from open fire or flame

    Do not use

    • over large areas of the body
    • in eyes
    • over raw or blistered areas

    Stop use and ask a doctor

    • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

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

  • Sting Relief Directions

    • adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
    • children under 2 years of age: consult a doctor.
  • Sting Relief Inactive ingredients

    benzalkonium chloride, menthol, and purified water

  • Sting Relief Questions or comments?

    1-800-430-5490

  • 4190 010885-4514 Kit Contents

    1 AMMONIA INHALANTS 10 PER

    1 TRIANGULAR BDG, NON-STERILE

    1 GAUZE COMPRESS, 1728 SQ IN 1

    1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

    1 ADH BDG W/NOADHR PAD,1X3 32PER

    1 BANDAGE COMP, 4" OFFSET, 1 PER

    1 1 OZ EYE WASH W/PADS & STRIPS

    1 PVP IODINE WIPES 10 PER

    1 ELASTIC BANDAGE 3" X 4.5YD

    1 MICROSHIELD W/VNL GLV/ALCL

    1 NORTH RESPONSE REFILL/KIT

    1 SCISSOR BDGE 4" RED PLS HDL

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    1 KIT STL 24 UN WHITE 01

    1 LABL INSTR 24 & 36 UNIT KITS

    1 STING RELIEF 10

  • Ammonia Inahalent Principal Display Panel

    Ammonia Inhalent

  • Eyewash Principal Display Panel

    Eyewash Label

  • PVP Principal Display Panel

    PVP Swab

  • Sting Relief Principal Display Panel

    Sting Relief

  • 4190 Kit Label 010885-4514

    4190 label

  • INGREDIENTS AND APPEARANCE
    4190 FIRST AID KIT 
    4190 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4190
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4190-011 in 1 KIT; Type 0: Not a Combination Product03/14/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 AMPULE 3 mL
    Part 21 BOTTLE 30 mL
    Part 310 POUCH 3 mL
    Part 410 POUCH 4 mL
    Part 510 POUCH 4 mL
    Part 1 of 5
    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 2 of 5
    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:0498-0100-0130 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 3 of 5
    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:0498-0121-000.3 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 4 of 5
    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 5 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0733-000.4 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 finalpart34812/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/14/2019
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical532775194manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)

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