4388 FIRST AID KIT- 4388 first aid 
Honeywell Safety Products USA, Inc.

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.

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0498-4388: First Aid Kit (ammonia, PVP wipes, Triple, NaCl irr, EW, BZK wipe, alcohol wipe, ASA, PAWS- Z346200)

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:

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

Triple
Other information

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

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

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

Alcohol Wipe
Other information

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

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

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

PVP Wipes
Other information

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

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

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:

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:

Stomach bleeding warning:

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

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

Aspirin
Other information

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

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

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

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)

Revised: 12/2021
Document Id: d3ea64e4-165d-4277-e053-2a95a90a4678
Set id: 96726c58-8d32-068f-e053-2a95a90ab622
Version: 3
Effective Time: 20211224
 
Honeywell Safety Products USA, Inc.