Label: 4195 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0730-01, 0498-4195-01
  • 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 March 10, 2019

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

  • Sting Relief Active ingredient

    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

  • Neomycin Antibiotic Ointment Active ingredient

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

  • Neomycin Antibiotic Ointment Purpose

    First aid antibiotic

  • Neomycin Antibiotic Ointment Uses

    first aid to help prevent infection in - minor cuts - scrapes - burns

  • Neomycin Antibiotic Ointment Warnings

    For external use only

    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

    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 reach of children

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

  • Neomycin Antibiotic Ointment 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 Antibiotic Ointment Other information

    store at 15 o to 25 oC (59 o to 77 oF)

  • Neomycin Antibiotic Ointment Inactive ingredient

    petrolatum

  • Neomycin Antibiotic Ointment 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 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

  • 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 information

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

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

  • PVP Questions and Comments

    1-800-430-5490

  • 4195 011597-1725 Kit Contents

    1 NEOMYCIN ANTIBIOTIC 10 PER

    1 GAUZE BANDAGE, 4" X 6 YD

    1 TRIANGULAR BDG, NON-STERILE

    1 INSTANT COLD PACK 4" X 6"

    1 BUFFERED EYE WASH 1 OZ BTL

    1 ADHESIVE BDG,PLSTIC,1"X3"16PER

    1 SPLINTER KIT

    1 PVP IODINE WIPES 10 PER

    1 BIOHAZARD BAGS

    2 CPR MICROSHIELD DOUBLE UNIT

    3 IVYX PRE TOWEL BULK 300/CS

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 PR LRG NITRILE GLVES ZIP BAG

    1 KIT STL 16 UN (VERTICAL)

    1 LABL INSTR FA REV A

    1 NOX A STING WIPES 10

  • Sting Relief Principal Display Panel

    Sting relief

  • Neomycin Antibiotic Ointment Principal Display Panel

    Neomycin

  • Eyewash Principal Display Panel

    Eyesaline

  • PVP Principal Display Panel

    PVP Swab

  • 4195 Kit Label 011597-1725

    4195 label

  • INGREDIENTS AND APPEARANCE
    4195 FIRST AID KIT 
    4195 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4195
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4195-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 POUCH 3 mL
    Part 21 BOTTLE 30 mL
    Part 310 POUCH 4 mL
    Part 410 PACKET 9 g
    Part 1 of 4
    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
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    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 2 of 4
    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 CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    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 finalpart34910/18/2018
    Part 3 of 4
    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
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  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
    10.4 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
    Part 4 of 4
    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 other10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical532775194manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)