Label: 4346 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-02, 0498-0221-59, 0498-0501-00, 0498-0750-35, view more
    0498-2422-01, 0498-4346-01
  • Packager: Honeywell Safety Products USA, INC
  • Category: HUMAN OTC DRUG LABEL

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 21, 2019

If you are a healthcare professional or from the pharmaceutical industry 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

  • Triple Active ingredients

    Bacitracin zinc 400 units

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

    Polymyxin B sulfate 5000 units

  • Triple Purpose

    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 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.

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

    petrolatum

  • Miralac Active ingredient (in each chewable tablet)

  • Miralac Purpose

    Antacid

  • Miralac Uses

    for the relief of

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

    Ask a doctor before use if you have

    • kidney stones
    • calcium-restricted diet

    Ask a doctor before use if you are

    • presently taking a prescription drug. Antacids may interfere with certain prescription drugs

    When using this product

    • do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

    Keep out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Miralac Directions

    • chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.
  • Miralac Other information

    • each tablet contains: calcium 170 mg
    • sucrose free
    • lactose free
    • store at room temperature
    • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
  • Miralac Inactive ingredients

    magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

  • Miralac 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

    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 Directions


    tear open packet and use as a washcloth

  • BZK Other information

    • store at room temperature 15 0 to 30 0 C (5 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactiave ingredient

    water

  • BzK Questions

    1-800-430-5490

  • Questions or Comments?

    1-800-430-5490

  • Pain Stopper Active ingredient (in each tablet)

    Acetaminophen 110mg

    Aspirin 162mg (NSAID)*

    Caffeine 32.4mg

    Salicylamide 152mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Pain Stopper Purpose

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Diuretic

    Pain reliever/fever reducer

  • Pain Stopper Uses

    for the temporary relief of minor aches and pains due to:

    • common cold

    • headache

    • muscular aches

    • premenstrual and menstrual cramps

  • Pain Stopper 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

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

    • skin reddening
    • blisters
    • rash

    If skin reaction occurs, stop use and seek medical help right away.

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

    • more than 12 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    Ask a doctor before use if

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

    Stop using and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pin that does not get better
    • if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.

    If pregnant or breast-feeding

    • ask a healthcare professional before use.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during pregnancy.

    KEEP OUT OF REACH OF CHILDREN.

    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 children even if you do not notice any signs or symptoms.

  • Pain Stopper Directions

    • adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
    • do not take more than 12 tablets in 24 hours
    • children under 12 years: consult a doctor
  • Pain Stopper Other information

    • store at a controlled room temperature 15 0 -30 0 C (59 0 -86 0 F)
    • TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN
  • Pain Stopper Inactive ingredients

    FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,

  • Pain Stopper Questions or Comments?

    1-800-430-5490

  • Burn relief WJ Active ingredient

    Lidocaine HCl 2%

  • Burn Relief WJ Purpose

    External analgesic

  • Burn Relief WJ Uses

    • temporarily relieves pain due to minor burns
  • Burn Relief WJ 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 the reach of children

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

  • Burn Relief WJ 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 Relief WJ Other information

    • store at room temperature
  • Burn Relief WJ Inactive ingredients

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

  • Burn Relief WJ Questions or Comments?

    1-800-430-5490

  • 4346 Z68140GRR KIT CONTENTS

    1 1X3 PLASTIC 100/BOX

    1 WOVEN 7/8 X 3 50/BOX

    1 SWIFT KNUCKLE 40/BX

    1 SWIFT FINGERTIP 8 50/BOX

    2 TRIPLE ANTIBIOTIC 10 PER

    1 EYE DRESS PKT W/4 ADH STRIPS

    1 INSTANT COLD PACK 4" X 6"

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

    1 TWEEZER PLASTICS 4"

    1 O/H PUMP BURN RELIEF 2 OZ ID G

    1 BLOODSTOPPER

    1 NON-ADHERENT PADS 2"X3" 10'S

    1 GZE PADS STERILE 3"X 3" 25'S

    2 ANTISEPTIC WIPES BZK CHL 20'S

    1 PAIN STOPPERS IND PK 2ENV 100

    1 MIRALAC TABS IND PK 2/ENV 100

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 F A KIT EMPTY BLANK 140

    1 POCKET INSERT RED #140 KIT 2R

    1 LBL STOCK 6-3/8"X4"

    1 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"

  • Eyewash Principal Display Panel

    Eyesaline

  • Triple Principal Display Panel

    Triple Antibiotic

  • Miralac Principal Display Panel

    Miralac

  • BZK Principal Display Panel

    Antiseptic Wipe

  • Pain Stopper Principal Display Panel

    Pain Stoppers

  • Burn Relieff WJ Principal Display Panel

    burn relief label

  • 4346 Kit Label Z68140GRR

    4346 label

  • INGREDIENTS AND APPEARANCE
    4346 FIRST AID KIT 
    4346 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4346
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4346-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 59 mL
    Part 320 PACKET 18 g
    Part 450 PACKET 100 
    Part 540 PACKET 56 mL
    Part 650 PACKET 100 
    Part 1 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 2 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
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0221-5959 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2018
    Part 3 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
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/19/2018
    Part 4 of 6
    MIRALAC 
    calcium carbonate tablet
    Product Information
    Item Code (Source)NDC:0498-0303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize11mm
    FlavorMINTImprint Code FR8
    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 finalpart33102/22/2012
    Part 5 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 finalpart333E12/22/2017
    Part 6 of 6
    PAIN STOPPERS 
    acetaminophen, caffeine, aspirin, salicylamide tablet
    Product Information
    Item Code (Source)NDC:0498-2422
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Colororange (BRIGHT ORANGE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2422-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/02/2017
    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(0498-4346)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2422, 0498-0303)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0750, 0498-0221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)