4229 FIRST AID KIT- 4229 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.

----------

4229 First Aid Kit ( alcohol wipes, ammonia, triple, aypanal, Pain stoppers- 68140FEDX)

Ammonia Inhalent
Active ingredient

Ammonia 15%

Ammonia Inhalent
Purpose

Respiratory stimulant

Ammonia Inhalent
Uses

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

Keep out of reach of children

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

Ammonia Inhalent
Directions

Ammonia Inhalent
Other information

Ammonia Inhalent
Other information

Ammonia Inhalent
Inactive ingredients

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

Ammonia Inhalent
Questions or Comments

1-800-430-5490

Alcohol Wipe
Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe
Purpose

First aid antiseptic

Alcohol Wipe
Uses

Alcohol Wipe
Warnings

For external use only

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 burn


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 Wipe
Directions

Alcohol Wipe
Other information

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

Alcohol Wipe
Inactive ingredient

water

Alcohol Wipe
Questions

1-800-430-5490

Aypanal
Active ingredient

Acetaminophen 325 mg

Aypanal
Purpose

Pain reliever/ fever reducer

Aypanaly
Uses

Keep out of reach of children.

Keep out of reach of children.

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:

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 before use if you have

  • liver disease


Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin


Stop using and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.


Overdose warning

  • In case of accidental overdose, get medical help or contact a Poison Control Center right away.
  • Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Aypanal
Directions

do not take more than directed (see overdose warning)

​adults and children 12 years of age or older

children 6 to under 12 years of age

children under 6 years consult a doctor

Aypanal
Other information

Aypanal
Inactive ingredients

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

Aypanal
Questions

1-800-430-5490

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

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

Ask a doctor before use if you have

  • a deep or puncture wounds
  • animal bites
  • serious burns

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

Pain Stoppers
Active ingredient

Acetaminophen 110mg

Aspirin 162mg (NSAID)*

Caffeine 32.4mg

Salicylamide 152mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Stoppers
Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Diuretic

Pain reliever/fever reducer

Pain Stoppers
Uses

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

• common cold

• headache

• muscular aches

• premenstrual and menstrual cramps

Pain Stoppers
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:

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

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

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

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

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

Do not use

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

Ask a doctor before use if

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding

  • ask a healthcare professional before use.

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

Keep out of reach of children

Overdose warning : In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Pain Stoppers
Directions

Pain Stoppers
Other information

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

Pain Stoppers
Inactive ingredients

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

Pain Stoppers
Questions or Comments?

1-800-430-5490

4229
68140FEDX Kit Contents

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 NITRILE GLOVES 2PR BBP

1 ADHESIVE TAPE W/P 1" X 10YDS

1 GAUZE BANDAGE 2"X2 YDS STRETCH GZ

1 FIRST AID GUIDE ASHI

1 BLOODSTOPPER

1 CTA STRL 6" SGL TIP 12/2

1 ALCOHOL WIPES 50'S

1 AYPANAL NON-ASP IND 2/ENV 100

1 PAIN STOPPERS IND PK 2ENV 250

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 F A KIT EMPTY BLANK 140

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 TRI BNDG NON WOVEN 40"X40"X56"

Ammonia inhalent
Principal Display Panel

Ammonia Inhalant

Alcohol Wipe
Principal Display Panel

OH Pak Alcohol Wipe

Aypanal
Principal Display Panel

Aypanal

Triple
Principal Display Panel

Triple antibiotic

Pain Stoppers
Principal Display Panel

Pain Stoppers

4229 Kit Label
68410FEDX

4229 label

4229 FIRST AID KIT 
4229 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4229
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4229-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PACKET 10 g
Part 2125 PACKET 250 
Part 310 AMPULE 3 mL
Part 450 POUCH 20 mL
Part 550 PACKET 100 
Part 1 of 5
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
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 2 of 5
PAIN STOPPERS 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Item Code (Source)NDC:0498-2422
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colororange (Bright Orange) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2422-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
Part 3 of 5
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 5
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 5
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(0498-4229)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(0498-2001, 0498-2422)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0750)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0143)

Revised: 3/2019
Document Id: 84c32265-fb4a-33c0-e053-2a91aa0a189e
Set id: 84c3c334-fe39-ca33-e053-2991aa0aba80
Version: 1
Effective Time: 20190323
 
Honeywell Safety Products USA, INC