Label: 4216 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-02, 0498-0114-01, 0498-0221-59, 0498-0501-00, view more
    0498-0750-36, 0498-3334-00, 0498-4216-01
  • 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 21, 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

  • Aspirin Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

  • Aspirin Purpose

    Pain reliever/fever reducer

  • Aspirin Uses

    temporarily reduces fever and relieves minor aches and pains associated with:

    • a cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual periods
  • Aspirin Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are:

    • age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • ringing in the ears or loss of hearing occurs
    • any new symptoms appear

    If pregnant or breast-feeding,

    If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


    Keep out of reach of children.

    • In case of overdose, get medical help or contact Poison Control Center right away.
  • Aspirin Directions

    • drink a full glass of water with each dose
    • adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years of age: consult a doctor
  • Aspirin Other information

    • store at room temperature 15° - 30°C (59° - 86°F)
    • TAMPER EVIDIENT PACKETS
    • DO NOT USE IF OPEN OR TORN
  • Aspirin Inactive ingredients

    corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

    *may contain these ingredients

  • Aspirin Questions or Comments

    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

  • BZK Wipes Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Wipe Purpose

    First aid antiseptic

  • BZK Wipes Uses

    • Antiseptic cleansing of face, hands, and body without soap and water
  • BZK Wipes 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 Wipe Directions

    • tear open packet and use as a washcloth
  • BzK Wipe Other information

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

    water

  • BZK Wipe Questions

    1-800-430-5490

  • Burn Spray Active ingredient

    Lidocaine HCl 2%

  • Burn Spray Purpose


    External analgesic

  • Burn Spray Uses

    • temporarily relievs pain due to minor burns
  • Burn Spray Warnings

    For external use only

    Do not use

    • over large areas of the body, particularly over raw surfaces or blistered areas


    When using this product

    • avoid contact with the eyes


    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of reach of children

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

  • Burn Spray Directions

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    children under 2 years of age: ask a doctor

  • Burn Spray Other information

    • store at room temperature
  • Burn Spray Inactive ingredients


    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

  • Burn Spray Questions or Comments?

    1-800-430-5490

  • Triple Active ingredient (each gram contains)

    Bacitracin zinc 400 units

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

    Polymyxin B sulfate 5000 units

  • Triple Purrpose

    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 alertdo 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 F)
    • tamper evident sealed packets
    • do not use if packet is torn or opened
  • Triple Inactive ingredient

    petrolatum

  • Triple Questions?

    1-800-430-5490

  • 4216 34120FP Kit Contents

    1 3/4 X 3 PLAS 100/BOX

    1 1X3 WOVEN SING 50/BOX

    1 AMMONIA INHALANTS 10 PER

    1 INSTANT COLD PACK 4" X 6"

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

    1 O/H PUMP BURN RELIEF 2 OZ ID G

    1 FIRST AID GUIDE ASHI

    3 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 BLOODSTOPPER

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

    1 3" COTTON TIPS 25 PER VIAL

    1 ANTISEPTIC WIPES BZK CHL 20'S

    2 ASPIRIN IND PK 5 GR 2/ENV 100

    1 TRIPLE BIOTIC .5 GRAM PKT 20

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    1 F A KIT EMPTY BLANK 120

    1 TONGUE BLADES SR WRAPPED 6'S

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    1 TRI BNDG NON WOVEN 40"X40"X56"

    10 NON ADHERENT PAD 2" X 3"

  • PRINCIPAL DISPLAY PANEL

    Eyesaline

  • Aspirin Principal Display Panel

    Aspirin

  • Ammonia Principal Display Panel

    Ammonia Inhalant

  • BZK Wipe Principal Display Panel

    Antiseptic Wipe

  • Burn Spray Principal Display Panel

    Burn Spray

  • Triple Principal Display Panel

    Triple Antibiotic

  • 4216 Kit Label 341420FP

    4216 label

  • INGREDIENTS AND APPEARANCE
    4216 FIRST AID KIT 
    4216 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4216
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4216-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 PACKET 10 g
    Part 21 BOTTLE 118 mL
    Part 320 PACKET 28 mL
    Part 4100 PACKET 200 
    Part 510 AMPULE 3 mL
    Part 61 BOTTLE, SPRAY 59 mL
    Part 1 of 6
    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:0498-0750-360.5 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 2 of 6
    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 3 of 6
    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 finalpart333E12/21/2017
    Part 4 of 6
    ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source)NDC:0498-0114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code FR21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0114-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/18/2018
    Part 5 of 6
    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 6 of 6
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Item Code (Source)NDC:0498-0221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2018
    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(0498-4216, 0498-0750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)