4154 FIRST AID KIT- 4154 first aid kit 
4139 FIRST AID KIT- 4139 first aid kit 
4313 FIRST AID KIT- 4313 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.

----------

4139, 4154, 4313 First Aid Kit (BZK wipes, FABC, ASA, ammonia- SF00004159, 68P25BR, SF00004513)

First Aid Burn Cream
Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream
Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream
Uses

First Aid Burn Cream
Warnings

For external use only

Do not use

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


Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days

First Aid Burn Cream
Directions

First Aid Burn Cream
Other information

First Aid Burn Cream
Inactive ingredients

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

First Aid Burn Cream
Questions

1-800-430-5490

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

BZK
Active ingredient

Benzalkonium chloride 0.13% w/v

BZK
Purpose

First aid antiseptic

BZK
Uses

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

BZK
Warnings


For external use only

Do not use

  • in the eyes or over large areas of the body
  • on mucous membranes
  • on irritated skin
  • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
  • longer than 1 week unless directed by a doctor

Keep out of reach of children

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

Stop use and ask a doctor if

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

BZK
Directions

BZK
Other information

BZK
Inactive ingredients

water

BZK
Questions

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 immidiately

Ammonia
Directions

Ammonia
Other information

Ammonioa
Inactive ingredients

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

Ammonia
Questions or Comments?

1-800-430-5490

4139
SF00004159 kit contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 INSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

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

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 # 25 EMPTY NO LOGO BLANK

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK

4154
68P25BR Kit Contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 INSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

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

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 KIT, PP 16 UNIT FA

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK

4313
SF00004513 kit contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 NSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

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

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 # 25 EMPTY NO LOGO BLANK

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK

First Aid Burn Cream
Principal Display Panel

First Aid Burn Cream

Aspirin
Principal Display Panel

Aspirin

BZK
Principal Display Panel

Antiseptic Wipe

Ammonia
Principal Display Panel

Ammonia Inhalant

4139 Kit Label
SF00004159

4139 label

4154 Kit Label
68P25BR

4154 label

4313 Kit Label
SF00004513

4313 label

4154 FIRST AID KIT 
4154 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4154
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4154-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PACKET 18 g
Part 21 PACKET 1.4 mL
Part 36 PACKET 12 
Part 43 AMPULE 0.9 mL
Part 1 of 4
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 4
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/18/2018
Part 3 of 4
ASPIRIN 
aspirin tablet
Product Information
Item Code (Source)NDC:0498-0114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0114-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/18/2018
Part 4 of 4
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4139 FIRST AID KIT 
4139 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4139
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4139-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PACKET 18 g
Part 21 PACKET 1.4 mL
Part 36 PACKET 12 
Part 43 AMPULE 0.9 mL
Part 1 of 4
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 4
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/18/2018
Part 3 of 4
ASPIRIN 
aspirin tablet
Product Information
Item Code (Source)NDC:0498-0114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0114-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/18/2018
Part 4 of 4
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4313 FIRST AID KIT 
4313 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4313
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4313-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PACKET 18 g
Part 21 PACKET 1.4 mL
Part 36 PACKET 12 
Part 43 AMPULE 0.9 mL
Part 1 of 4
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 4
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/18/2018
Part 3 of 4
ASPIRIN 
aspirin tablet
Product Information
Item Code (Source)NDC:0498-0114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0114-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/18/2018
Part 4 of 4
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
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(0498-4154, 0498-4139, 0498-4313)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(0498-0114)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0903)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0501)

Revised: 5/2019
Document Id: 8893cf36-e2c3-20f2-e053-2995a90a6e29
Set id: 87ee593d-667a-f592-e053-2a95a90a17b1
Version: 3
Effective Time: 20190510
 
Honeywell Safety Products USA, INC