Label: 4135 FIRST AID KIT- 4135 first aid

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0501-00, 0498-0750-35, view more
    0498-3334-00, 0498-4135-01
  • 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.

  • Active ingredient

    Ammonia 15%

    Close
  • Purpose

    Respiratory stimulant

    Close
  • Uses

    to prevent or treat fainting

    Close
  • Warnings

    For external use only

    Do not use

    • if you have asthma or emphysema

    Stop use and ask a doctor if

    • condition persists
    Close
  • Keep out of reach of children

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

    Close
  • 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
    Close
  • Other information

    store at room temperature away from light

    Close
  • Inactive ingredients

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

    Close
  • Questions or Comments

    1-800-430-5490

    Close
  • PVP Active ingredient

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

    Close
  • PVP Purpose

    First aid antisepti

    Close
  • PVP Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burn
    Close
  • 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
    Close
  • PVP Directioons

    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
    Close
  • 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
    Close
  • PVP Inactive ingredients

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

    Close
  • PVP Questions and Comments?

    1-800-430-5490

    Close
  • Triple Active ingredient

    Bacitracin zinc 400 units

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

    Polymyxin B sulfate 5000 units

    Close
  • Triple Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Close
  • Triple Uses


    first aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns
    Close
  • 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.

    Close
  • 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
    Close
  • 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
    Close
  • Triple Inactive ingredient

    petrolatum

    Close
  • Triple Questions?

    1-800-430-5490

    Close
  • BZK Wipe Active ingredient

    Benzalkonium chloride 0.13% w/v

    Close
  • BZK Wipe Purpose

    First aid antiseptic

    Close
  • BzK Wipe Uses

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

    Close
  • BZK Wipe 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.

    Close
  • BZK Wipe Directions

    tear open packet and use as a washcloth

    Close
  • BZK Wipe Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
    Close
  • BZK Wipe Other information

    water

    Close
  • BZK Wipe Questions

    1-800-430-5490

    Close
  • 4135 SF00001642 Kit Contents

    1 3/4 X 3 PLAS 100/BOX

    1 TRIPLE ANTIBIOTIC 10 PER

    2 INSTANT COLD PACK 4" X 6"

    1 1 OZ EYE WASH W/PADS & STRIPS

    4 PVP IODINE WIPES 10 PER

    1 ANTIMCRBL ANTSPTC TWLETTS

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

    1 FIRST AID GUIDE ASHI

    6 GAUZE CLEAN-WRAP BDGE N/S 2"

    2 ABD COMBINE PAD 5" X 9"

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

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 ZIP BAG FOR 50 ECONO

    1 KIT STL BULK MEDIUM

    1 TRI BNDG NON WOVEN 40"X40"X56"

    Close
  • Principal Display Panel
  • PVP Principal Display Panel
  • Triple Principal Display Panel
  • BZK Wipe Principal Display Panel
  • 4135 Kit Label SF00001642
  • INGREDIENTS AND APPEARANCE
    4135 FIRST AID KIT 
    4135 first aid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4135
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4135-01 1 in 1 KIT 09/13/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 4 AMPULE 1.2 mL
    Part 2 40 POUCH 12 mL
    Part 3 1 BOTTLE 30 mL
    Part 4 10 PACKET 9 g
    Part 5 1 PACKET 1.4 mL
    Part 1 of 5
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source) NDC:0498-3334
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/18/2018
    Part 2 of 5
    PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source) NDC:0498-0121
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0121-00 0.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/18/2018
    Part 3 of 5
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source) NDC:0498-0100
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0100-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 12/18/2018
    Part 4 of 5
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source) NDC:0498-0750
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0750-35 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 09/19/2018
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0501-00 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/22/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/13/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products USA, Inc. (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander 040756421 manufacture(0498-3334)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 pack(0498-4135)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0750)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0501)
    Establishment
    Name Address ID/FEI Business Operations
    Sion Biotext Medical 532775194 manufacture(0498-0121)
    Close