Label: 4388 FIRST AID KIT- 4388 first aid kit

  • NDC Code(s): 0498-0100-02, 0498-0114-01, 0498-0121-00, 0498-0143-04, view more
    0498-0501-00, 0498-0750-35, 0498-3334-00, 0498-4388-01
  • 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 November 3, 2019

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

  • Triple Active ingredient

    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

  • Triple Questions?

    1-800-430-5490

  • BZK Wipe Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Wipe Purpose

    First aid antiseptic

  • BzK Wipe Uses

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

  • 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.

  • 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

  • Isotonic Solution for Irrigation.

    For Irrigation Only.

    Not for Injection.

  • NaCL Irrigant Description


    Each 100 mL contains:
    Sodium Chloride USP 0.9 g; Water for Injection USP qs

    pH adjusted with Hydrochloric Acid NF
    pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter

    Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
    0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

    The formula of the active ingredient is:
    Ingredient Molecular Formula Molecular Weight
    Sodium Chloride USP NaCl 58.44

    The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

    The PIC™ Container is PVC-free and DEHP-free.


    Ingredient Molecular Formula Molecular Weight
    Sodium Chloride USP NaCl 58.44

    The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

    The PIC™ Container is PVC-free and DEHP-free.

  • NaCL Irrigant Clinical Pharmacology

    0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

    0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).

    Physiological irrigation solutions are considered generally compatible with living tissues and organs.

    Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

    Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

  • Indication and Usage NaCl Irrigant

    0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

  • NaCl Irrigant Contraindications

    0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.

    An electrolyte solution should not be used for irrigation during electrosurgical procedures.

  • Warnings NaCl Irrigant

    FOR IRRIGATION ONLY. NOT FOR INJECTION.

    Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

    The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

    Do not warm above 150°F (66°C).

    After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

    Discard unused portion of irrigating solution since it contains no preservatives.

  • Precautions NaCl Irrigant

    General
    Use aseptic technique when preparing and administering sterile irrigation solutions.

    Use only if solution is clear and container and seal are intact.

    Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.

    Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

    When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

    Laboratory Tests

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid absorption is suspected, or whenever the condition of the patient warrants such evaluation.

    Drug Interactions

    Some additives may be incompatible. Consult with pharmacist.When introducing additives, use aseptic technique.Mix thoroughly.

    Do not store.


    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with 0.9% Sodium Chloride Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

    Pregnancy

    Teratogenic Effects

    Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation USP. It is also not known whether 0.9% Sodium Chloride Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation USP should be given to a pregnant woman only if clearly needed.

    Labor and Delivery

    Safety and effectiveness of 0.9% Sodium Chloride Irrigation USP during labor and delivery have not been established. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Irrigation USP is administered to a nursing woman.

    Pediatric Use

    The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

    Geriatric Use

    Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.

  • Adverse Reactions

    Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

    If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

  • Overdosage

    In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravasular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

  • Dosage and Administration

    As required for irrigation.

    When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

    Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

    Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

  • How Supplied

    0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case.

    0.9% Sodium Chloride Irrigation USP


    NDC Cat. No. REF SIZE

    0264-2201-00 R5200-01 1000 mL
    0264-2201-10 R5201-01 500 mL
    0264-2201-50 R5205-01 2000 mL
    0264-2201-70 R5207 ,,,,4000 mL

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

    Do not warm above 150°F (66°C).

  • SPL Unclassified Section

    Rx only

    Revised: March 2009

    PIC is a trademark of B. Braun Medical Inc.

  • SPL Unclassified Section

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    Y36-002-699

  • Alcohol Wipe Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Wipe Purpose

    First aid antiseptic

  • Alcohol Wipe Uses

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

    For external use only

    Flammable, keep away from fire and flame

    Do not use

    • in or near 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 1 week unless directed by a doctor


    Stop use and consult a doctor if

    • condition persists or gets worse


    Keep out of the reach of children


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

  • Alcohol Wipe Directions

    • clean the affected area
    • may be covered with a sterile bandage
    • apply wipe to affeted are 1 to 3 times daily
    • discard wipe after single use
  • Alcohol Wipe Other information

    • store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)
    • do not use if packet is torn or opened
  • Alcohol Wipe Inactive ingredient

    water

  • Alcohol Wipe Questions

    1-800-430-5490

  • Ammonia Inhalent Active ingredient

    Ammonia 15%

  • Ammonioa Inhalent Purpose

    Respiratory stimulant

  • Ammonia Inhalent Uses

    to prevent or treat fainting

    Keep out of reach of children

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

  • Ammonia Inhalent 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
  • Ammonia Inhalent 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 Inhalent Other information

    store at room temperature away from light

  • Ammonia Inhalent Inactive ingredients

    alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water at room temperature away from light

  • Ammonia Inhalent Questions or Comments?

    1-800-430-5490

  • PVP Wipe Active ingredient

    Povidone-iodine 10% (equivalent to 1% titratable iodine)

  • PVP Wipe Purpose

    First aid antiseptic

  • PVP Wipe Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • PVP Wipes Warnings

    For external use only.

    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 or persists for more than 72 hours
    • irritation and redness develops

    Keep out of reach of children.

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

  • PVP Wipes Directions

    • clean the affected area
    • apply1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
    • discard wipe after single use
  • PVP Wipes Other information

    • do not use on individuals who are allergic or sensitive to iodine
    • store at controlled temperature 59-86ºF (15-30ºC)
    • do not use if pouch is open or torn
  • PVP Wipes Inactive inngredients

    nonoxynol 9, water

  • PVP Wipes Questions

    800-430-5490

  • PAWS Active ingredient

    Ethyl alcohol 66.5%

  • PAWS Purpose

    Antiseptic

  • PAWS Uses

    • for handwashing to decrease bacteria on skin whenever soap and water is not readily available
  • PAWS Warnings

    For external use only

    Flammable: keep away from fire or flame

    Do not use in the eyes.

    If this happens, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develop and persists for more than 72 hours

    Keep out of reach of children

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

  • PAWS Directions

    • wet hands and wrists thoroughly for 15 seconds and allow to air dry
    • always reseal after use
    • children under 6 years of age should be supervised when using this product
  • PAWS Inactive ingredients

    aloe vera, fragrance, purified water, triethanolamine

  • PAWS Questions

    1-800-430-5490

  • Aspirin Active ingredient

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug
    c

  • Aspirin Purpose


    Pain reliever/fever reducerv

  • 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

  • Eyewash Active ingredient

    Sterile Water 99%

  • Eyewash Purpose

    Eyewash

  • Eyewash Uses

    • for flushing the eye to remove loose foreign material, air pollutants or chlorin
  • 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?

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

  • 4387 346200/M Kit Contents

    1 AMMONIA INHALANTS 10 PER

    1 EYE DRESS PKT W/4 ADH STRIPS

    1 ALCOHOL PREP PADS 10P

    1 PVP IODINE WIPES 10 PER

    1 NITRILE GLOVES 2PR BBP

    2 O/H TAPE ADHESIVE TRI-CUT

    4 BK GZ 4.5"X4.1YD6PLY RL ST MSO

    1 FIRST AID GUIDE ASHI

    2 EMERGENCY SURVIVAL BLANKET

    2 BLOODSTOPPER

    2 ABD COMBINE PAD 5" X 9"

    2 ABD PADS 8"X10" STERILE

    2 MULTI-TRAUMA DRESSING 12"X30"

    1 BURN SHEET STERILE 60"X90"

    1 SOD. CHLORIDE 0.9% 500ML EA

    1 EMPTY BAG RED 12X12X10

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 EMER.YELLOW BLKT 54"X80" POLYP

    1 BANDAGE PACK FOR KIT

    1 ZIP LOCK BAG FOR KIT #2

    1 ZIP LOCK BAG FOR KIT #3

    2 SELF-ADH WRAP 3 X 5 YDS NORTH REV E

    1 WATER-JEL BURN DRESSING 4 X 4

    2 COLD PACK UNIT 4"X6" BULK

    1 CPR MSK,WPS,GLVS 1

  • Triple Principal Display Panel

    Triple Antibiotic

  • BZK Wipe Principal Display Panel

    Antiseptic Wipe

  • Principal Display Panel 500 ml Container

    NaCL Irrigation USP

  • Alcohol Wipe Principal Display Panel

    Alcohol Preps

  • Ammonia Inhalent Principal Display Panel

    Ammonia Inhalent

  • PVP Wipes Principal Display Panel

    PVP Wipe

  • PAWS Principal Display Panel

    Paws

  • Aspirin Principal Display Panel

    Aspirin

  • Eyewash Principal Display Panel

    Eyesaline

  • 4387 Kit Label 346200/M

    4387 label

  • INGREDIENTS AND APPEARANCE
    4388 FIRST AID KIT 
    4388 first aid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4388
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4388-011 in 1 KIT09/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET 2.7 g
    Part 26 PACKET 8.4 mL
    Part 310 AMPULE 3 mL
    Part 416 POUCH 6.4 mL
    Part 51 CONTAINER 500 mL
    Part 610 POUCH 3 mL
    Part 72 PACKET 0.0038 L
    Part 812 PACKET 24 
    Part 91 BOTTLE 118 mL
    Part 1 of 9
    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 2 of 9
    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 3 of 9
    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 4 of 9
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:0498-0143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2018
    Part 5 of 9
    SODIUM CHLORIDE 
    sodium chloride irrigant
    Product Information
    Item Code (Source)NDC:0264-2201
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01673309/14/2009
    Part 6 of 9
    PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source)NDC:0498-0121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 7 of 9
    PAWS 
    ethyl alcohol liquid
    Product Information
    Item Code (Source)NDC:0498-3111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.0019 L 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 8 of 9
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    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 9 of 9
    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 not finalpart34912/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/13/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products USA, Inc. (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    B. Braun Medical Inc.037425308label(0264-2201)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-4388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Medical Biotext532775194manufacture(0498-0501, 0498-0143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc167518617manufacture(0498-3111)