4134 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]

4134 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-0100-01, 0498-0114-01, 0498-0501-00, 0498-4134-01
Set ID 8828ae97-a03b-e664-e053-2a95a90abe4f
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, INC
Generic Name
Product Class
Product Number
Application Number
  • First Aid Burn Cream Active ingredient

    Benzalkonium chloride o.13%

    Lidocaine HCl 0.5%

  • First Aid Burn Cream Purpose

    First aid antiseptic

    External analgesic

  • First Aid Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
  • First Aid Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • First Aid Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • First Aid Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

  • First Aid Burn Cream 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

  • 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

  • BZK Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

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

  • BZK 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

    Keep out of reach of children

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

    Stop use and ask a doctor if

    • irritation, redness or other symptoms develop
    • the condition persists or gets worse
  • BZK Directions

    • tear open packet and use as a washcloth
  • BZK Other information

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

    water

  • BZK Questions

    1-800-430-5490

  • 4134 SF00004169 Kit Contents

    1 3/4 X 3 PLAS 100/BOX

    1 TRIANGULAR BDG, NON-STERILE

    1 INSTANT COLD PACK 4" X 6"

    3 ANTIMCRBL ANTSPTC TWLETTS

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

    1 TWEEZER PLASTICS 4"

    1 GAUZE CLEAN-WRAP BDGE N/S 4"

    1 ABD COMBINE PAD 5" X 9"

    1 1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 # 25 EMPTY NO LOGO BLANK

    1 F. A. INST CHART SM (INDIVIDUAL LBL)

    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

    6 FIRST AID CREAM 1.0GR PKT EACH

    2 ADHES TAPE EYE STRIPS 2'S

    2 EYE PADS STD OVAL STERILE

    5 GAUZE PADS 4"X4" 12PLY

    12 ASPIRIN BULK 2/PK

  • First Aid Burn Cream Principal Display Panel

    First Aid Burn Cream

  • Eyewash Principal Display Panel

    Eyewash Label

  • Aspirin Principal Display Panel

    Aspirin

  • BZK Principal Display Panel

    Antiseptic Wipe

  • 4134 Kit Label SF00004169

    4134 label

  • INGREDIENTS AND APPEARANCE
    4134 FIRST AID KIT 
    4134 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4134
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4134-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 PACKET 5.4 g
    Part 21 BOTTLE 30 mL
    Part 33 PACKET 4.2 mL
    Part 412 PACKET 24 
    Part 1 of 4
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    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 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 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 finalpart333E09/18/2018
    Part 4 of 4
    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
    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(0498-4134)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)

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