4240 FIRST AID KIT- 4240 first aid kit 
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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4240 First Aid Kit (1st aid Sp, EW, ASA, aypanal, miralac, amm. Inh, triple, burn spray WS, alcohol wipe, BZK wipes - 68400LNODEA)

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

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:

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:are:

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

Ammonia
Active ingredient

Ammonia 15%

Ammonia
Purpose

Respiratory stimulant

Ammonia
Uses

Ammonia
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

Keep out of reach of children

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

Ammonia
Directions

Ammonia
Other information

Ammonia
Inactive ingredient

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Ammonia
Questions or Comments?

1-800-430-5490

Water Soluble 1st Aid Spray
Active ingredient

Benzethonium chloride 0.2% w/w - Benzocaine 10% w/w

Water Soluble 1st Aid Spray
Purpose

Topical antiseptic

Topical anesthetic

Water Soluble 1st Aid Spray
Uses

for temporary relief of pain and itching and helps protect against infection in

Water Soluble 1st Aid Spray
Warnings

For external use only

Flammable

Do not use

  • in the eyes or other mucous membranes
  • in cases of serious burns
  • in case of deep orpuncture wounds
  • for a prolonged period of time
  • on large portion of the body


Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
  • redness, swelling, or irritation occurs

Keep out of reach of children

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

Water Soluble 1st Aid Spray
Directions

Water Soluble 1st Aid pray
Other information

Water Soluble 1st Aid pray
Inactive ingredients


dipropylene glycol, isobutane, N-butane, propane

Burn Relief Water Soluble
Active ingredients

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Relief Water Soluble
Purpose


Topical antiseptic

Topical anesthetic

Topical anesthetic

Burn Relief Water Soluble
Uses

for the temporary relief of pain and itching and helps protect against infection in:

Burn Relief Water Soluble
Warnings

For external use only

Flammable keep away from fire or flame

Do not use

  • in or near the eyes or other mucous membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling, or irritation occurs

Keep out of the reach of children

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

Burn Relief Water Soluble
Directions

Burn Relief Water Soluble
Other information

Burn Relief Water Soluble
Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

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

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

Alcohol
Active ingredient

Isopropyl alcohol 70%

Alcohol
Purpose

First aid antiseptic

Alcohol
Uses

Alcohol
Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

  • in the eyes
  • over large areas of the body


Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

  • do not use longer than one week unless directed by a doctor

Stop use and consult a doctor

  • if condition persists or gets worse

Keep out of reach of children

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

Alcohol
Directions

Alcohol
Other information

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

Alcohol
Inactive ingredient

water

Miralac
Active ingredient (in each chewable tablet)

Miralac
Active ingredient (in each chewable tablet)

Calcium carbonate 420 mg

Miralac
Purpose

Antacid

Miralac
Uses

for the relief of


Warnings

Ask a doctor before use if you have

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

Miralac
Other information

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

BZK
Inactiave ingredient

water

BzK
Questions

1-800-430-5490

Aypanal
Active ingredient

Acetaminophen 500 mg

Aypanal
Purpose

Pain reliever/fever reducer

Aypanal
Uses

Ask a doctor before use if you have

  • liver disease

Aypanal
Warnings

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

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

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

Do not use

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

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breastfeeding

  • ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

Overdose warning: In case ofl overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Aypanal
Directions

Aypanal
Other information

Aypanal
Inactive igredients

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

Aypanal
Questions or Comments

1-800-430-5490

4240
68400LNODEA KIT CONTENTS

1 3/4 X 3 PLAS 100/BOX

1 1X3 PLASTIC 100/BOX

1 WOVEN 2" X 3" 25/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 1X3 WOVEN SING 50/BOX

1 SWIFT KNUCKLE 40/BX

1 AMMONIA INHALANTS 10 PER

1 ELASTIC TAPE 1" X 5YD

1 FORCEPS POINTED METAL

1 O/H TAPE ADHESIVE TRI-CUT

1 FIRST AID GUIDE ASHI

6 GAUZE CLEAN-WRAP BDGE N/S 2"

2 BLOODSTOPPER

1 NON ADHERENT PADS 2"X3" 50'S

2 GZE PADS STERILE 2"X 2" 25'S

1 GZE PADS STERILE 4"X 4" 25'S

1 CO-FLEX BANDAGE 2"X 5YDS TAN

1 COTTON TIPS 100 PER VIAL

1 ANTISEPTIC WIPES BZK CHL 20'S

1 FIRST AID SPRAY AEROSOL 3 OZ

1 ALCOHOL WIPES 50'S

1 ASPIRIN IND PK 5 GR 2/ENV 250

1 AYPANAL NON-ASP IND 2/ENV 100

1 MIRALAC TABS IND PK 2/ENV 250

1 BURN SPRAY 3 OZ

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 COLD PACK 5"X9" BOXED

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 400 EMPTY KIT BLANK

1 POCKET INSERT RED #400 KIT 5R

1 TONGUE BLADES SR WRAPPED 6'S

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

2 TRI BNDG NON WOVEN 40"X40"X56"

1 RED BIO BAGS 2/BX

Eyewash
Principal Display Panel

Eyesaline

Aspirin
Principal Display Panel

Aspirin

Ammonia
Principal Display Panel

Ammonia Inhalant

Water Soluble 1st Aid Spray
Principal Display Panel

Water Soluble 1st Aid Spray

Burn Relief Water Soluble
Principal Display Panel

Burn Spray

Triple
Principal Display Panel

Triple Antibiotic

Alcohol
Principal Display Panel

Alcohol Preps

Miralac
Principal Display Panel

Miralac

BZK
Principal Display Panel

Antiseptic Wipe

Aypanal
Principal Display Panel

Aypanal

4240 Kit Label
68400LNODEA

4240 label

4240 FIRST AID KIT 
4240 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4240
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4240-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1125 PACKET 250 
Part 21 BOTTLE 118 mL
Part 3125 PACKET 250 
Part 410 AMPULE 3 mL
Part 51 CAN 85 g
Part 61 CAN 85 g
Part 720 PACKET 10 g
Part 850 POUCH 20 mL
Part 920 PACKET 28 mL
Part 1050 PACKET 100 
Part 1 of 10
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 2 of 10
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 3 of 10
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
Part 4 of 10
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 5 of 10
FIRST AID ANTISEPTIC WATER SOLUBLE 
benzethonium chloride, benzocaine spray
Product Information
Item Code (Source)NDC:0498-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0031-4085 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/19/2018
Part 6 of 10
BURN WATER SOLUBLE 
benzocaine, benzethonium chloride, menthol spray
Product Information
Item Code (Source)NDC:0498-0021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.33 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0021-4085 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/12/2018
Part 7 of 10
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:0498-0750-360.5 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 8 of 10
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 9 of 10
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 10 of 10
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/10/2012
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
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4240)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(0498-0114, 0498-2001, 0498-0303)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments115315822manufacture(0498-0031, 0498-0021)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0750)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0143, 0498-0501)

Revised: 4/2019
Document Id: 858054cb-5248-2cbd-e053-2a91aa0ac5f5
Set id: 85809d69-3b29-1e7f-e053-2a91aa0a3e16
Version: 1
Effective Time: 20190401
 
Honeywell Safety Products USA, INC