Label: 4263 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-01, 0498-0501-00, 0498-0730-01, 0498-4263-01
  • 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 April 10, 2019

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

  • Eyesaline Active ingredient

    Sterile Water 99%

  • Eyesaline Purpose

    Eyewash

  • Eyesaline Uses

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

  • Eyesaline 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
  • Eyesaline Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Eyesaline Questions

    1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

  • Aypanal Active ingredient

    Acetaminophen 325 mg

  • Aypanal Purpose

    Pain reliever/ fever reducer

  • Aypanal Uses

    • temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever

    Keep out of reach of children.

    Keep out of reach of children.

  • Aypanal Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product:

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin rash occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription).
    • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    • liver disease


    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin


    Stop using and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.


    Overdose warning

    • In case of accidental overdose, get medical help or contact a Poison Control Center right away.
    • Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
  • Aypanal Directions

    do not take more than directed (see overdose warning)

    ​adults and children 12 years of age or older

    • take two tablets every 4-6 hours while symptoms last
    • do not take more than 12 tablets in 24 hours

    children 6 to under 12 years of age

    • take 1 tablet every 4-6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours

    children under 6 years consult a doctor

  • Aypanal Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
  • Aypanal Inactive ingredients

    corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

  • Aypanal Questions

    1-800-430-5490

  • Neomycin Active ingredient

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

  • Neomycin Purpose

    First aid antibiotic

  • Neomycin Uses

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

    Do not use

    • in the eyes
    • over large areas of the body
  • Neomycin 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

    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    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 Direction

    • 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 Other information


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

  • Neomycin Inactive ingredient

    petrolatum

  • Neomycin Questions?

    1-800-430-5490

  • BZK Active ingredient

    Benzalkonium chloride 0.13%

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

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

    For external use only

    Do not use

    • in or near 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 ask a doctor if

    • 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

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • BZK Other information

    • shake well
    • store at room temperature 15 0 -30 0 C (59 0 -86 0 F)
  • BZK Inactive ingredients

    iazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

  • BZK Questions

    1-800-430-5490

  • Eyesaline Principal Display Panel

    Eyesaline

  • Aypanal Principal Display Panel

    Aypanal

  • Neomycin Principal Display Panel

    Neomycin

  • BZK Principal Display Panel

    Antiseptic Wipe

  • 4263 Kit Label SF00000637

    4263 label

  • 4263 Kit Contnets SF00000637

    1 NEOMYCIN ANTIBIOTIC 10 PER

    1 GAUZE BANDAGE, 4" X 6 YD

    1 TWEEZER PLASTICS 4"

    1 ABD COMBINE PAD 5" X 9"

    1 CPR FILTERSHIELD 77-100

    1 1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    10 BZK ANTISEPTIC WIPE, BULK

    2 PR LRG NITRILE GLVES ZIP BAG

    1 TAPE ADHESIVE 1/2 X 2.5 125133

    1 KIT, PP 16 UNIT FA

    1 LABL INSTR FA REV A

    1 TRI BNDG NON WOVEN 40"X40"X56"

    1 COLD PACK UNIT 4"X6" BULK

    2 EYE PADS STD OVAL STERILE

    5 GAUZE PADS 4"X4" 12PLY

    20 PLASTIC BANDAGE 3/4" X 3"

    20 PLASTIC BANDAGE 1" X 3"

    5 AYPANAL BULK 2/PK

  • INGREDIENTS AND APPEARANCE
    4263 FIRST AID KIT 
    4263 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4263
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4263-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 mL
    Part 25 PACKET 10 
    Part 310 PACKET 9 g
    Part 410 PACKET 14 mL
    Part 1 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 finalpart34912/18/2018
    Part 2 of 4
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 3 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
    Part 4 of 4
    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
    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(0498-4263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2001)
    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
    Changzhou Maokang Medical421317073manufacture(0498-0501)