4246 FIRST AID KIT- 4246 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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4246 First Aid Kit (Burn Jel, alcohol wipes, HC cr, Burn Relief pump, PVP wipes, EW, ASA, amm. Inh, Foille Burn, Aypanal - 340420FP)

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

Burn Jel
Active ingredient

Lidocaine HCl 2.0 %

Burn Jel
Purpose

External analgesic

Burn Jel
Uses


temporarily relieves pain due to minor burns

Stop use and ask a doctor if

  • the condition gets worse
  • symptoms persist for more than 7 days
  • condition clears up and recurs within a few days

Burn Jel
Warnings

For external use only

Do not use

  • on large areas of the body, particularly over raw surfaces or blistered areas

When using this product

  • avoid contact with eyes

Keep out of reach of children

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

Burn Jel
Directions

Burn Jel
Other information

store at room temperature
do not use if opened or torn

Burn Jel
Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel
Questions

1-800-430-5490

Alcohol Wipes
Active ingredient

Isopropyl alcohol 70%

Alcohol Wipes
Purpose

First aid antiseptic

Alcohol Wipes
Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Keep out of the reach of children

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

Alcohol Wipes
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

Alcohol Wipes
Directions

Alcohol Wipes
Other information

Alcohol Wipe
Inactive ingredient

water

Alcohol Wipe
Questions

1-800-430-5490

Hydrocortisone
Acitive ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone
Purpose

Anti-itch cream

Hydrocortisone
Uses

for the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone
Warnings

For external use only

Ask a doctor before use if

  • you are using any other hydrocortisone product

When using the product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Stop use and ask a doctor if

  • condition worsens
  • condition persists for more than 7 days
  • condition clears up and recurs within a few days

Keep out of reach of children

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

Hydrocortisone
Directions

Hydrocortisone
Other information

Hydrocortisone
Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Hydrocortisone
Questions or Comments?

1-800-430-5490

PVP Wipe
Active ingredient


Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

PVP Wipe
Purpose

First aid antiseptic

PVP Wipe
Uses

Stop use and ask a doctor if

  • conditions persists or gets worse
  • irritation and redness develops

PVP Wipe
Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • on individuals who are allergic or sensitive to iodine

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 wek unless directed by a doctor

Keep out of reach of children.

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

PVP Wipe
Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

PVP
Other information

PVP
Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

PVP
Questions and Comments?

1-800-430-5490

Burn Relief
Active ingredient

Lidocaine HCL 2%

Burn Relief Spray
Purpose

External analgesic

Burn Spray
Uses

temporarily relieves pain due to minor burns

Burn Relief Spray
Warnings

For external use only

Do not use

  • over large areas of the body, particularly over raw surfaces or blistered areas

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

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

Keep out of the reach of children

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

Burn Relief
Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

children under 2 years of age: ask a doctor

Burn Relief Spray
Other information

Burn Reelief Spray
Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Burn Relief Spray
Questions or Comments?

1-800-430-5490

Aypanal
Active ingredient

Acetaminophen 325 mg

Aypanal
Purpose

Pain reliever/fever reducer

Aypanal
Uses

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 a skin rash 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 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

  • ask a health professional before use.

Keep out of reach of children

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 for children even if you do not notice any signs or symptoms.

Aypanal
Directions

Aypanal
Other information

Aypanal
Inactive ingredients

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

Aypanal
Questions or Comments?

1-80-430-5490

Foille Ointment
Active ingredient


Benzocaine 5.0% (w/w)
Chloroxylenol 0.1% (w/w)

Foille Ointment
Purpose

External analgesic

Antiseptic

Foille Ointment
Uses

Foille Ointment
Warnings

For external use only.

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

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

  • do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Keep out of reach of children.


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

Foille Ointment
Directions

Foille Ointment
Other information

Foille Oinatment
Inactive ingredients

beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, eugenol, hydrogenated vegetable oil, maleic anhydride, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil.

4246
68100REC Kit Contents

1 3/4 X 3 PLAS 100/BOX

1 1X3 PLASTIC 100/BOX

1 KING SIZE 2 X 3 PLASTIC 50/BX

1 AMMONIA INHALANTS 10 PER

1 GAUZE COMPRESS, 1728 SQ IN 1

4 INSTANT COLD PACK 4" X 6"

3 BANDAGE COMP, 4" OFFSET, 1 PER

1 BURN JEL 1/8 OZ, 6 PER

1 ALCOHOL PREP PADS 10P

1 HYDROCORTISON,1.O%,1/32 OZ,10P

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

2 O/H PUMP BURN RELIEF 2 OZ ID G

2 GAUZE BANDAGE 1" x 2 YDS

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

6 TAPE ADHESIVE 1"X 5 YD PLSTC

2 GZE PADS STERILE 2"X 2" 10'S

2 GZE PADS STERILE 3"X 3" 10'S

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

5 CO-FLEX BAND 1"X5YD TAN 2/PACK

2 CO-FLEX BANDAGE 4"X5YDS TAN

1 PVP PREP PADS MEDIUM 100/BX

1 ASPIRIN IND PK 5 GR 2/ENV 100

1 212 4 OZ TUBE SKIN COND, 1 EA ID P

2 1 OZ, BUFF EYEWASH

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 180 EMPTY BLANK NO LOGO

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 SELF-ADH WRAP 3 X 5 YDS NORTH REV E

2 TRI BNDG NON WOVEN 40"X40"X56"

2 FOILLE BURN/F A OINT 1/2 OZ

8 EYE PADS STD OVAL STERILE

5 GAUZE PADS 4"X4" 12PLY

1 WOVEN KNUCKLE 8'S

1 FINGERTIP "T" 8/BX

1 TRNQT W/WEB STP&BKL 1

1 AYPANAL NON-ASP 25/2

Eyesaline

Aspirin
Principal Display Panel

Aspirin

Ammonia
Principal Display Panel

Ammonia Inhalant

Burn Jel
Principal Display Panel

Burn Jel

Alcohol Wipe
Principal Display Panel

Alcohol Preps

Hydrocortisone
Principal Display Panel

Hydrocortisone

PVP
Principal Display Panel

PVP label

Burn Relief Spray
Principal Display Panel

Burn Relief Spray

Aypanal
Principal Display Panel

Aypanal

Foille Ointment
Principal Display Panel

Foille Ointment

4246 Kit Label
68100REC

4246 label

4246 FIRST AID KIT 
4246 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4246
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4246-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 TUBE 28 g
Part 210 PACKET 9 g
Part 32 BOTTLE 60 mL
Part 450 PACKET 100 
Part 510 AMPULE 3 mL
Part 62 BOTTLE, SPRAY 118 mL
Part 710 POUCH 4 mL
Part 8100 POUCH 30 mL
Part 96 PACKET 21 g
Part 1010 PACKET 9 g
Part 1125 PACKET 50 
Part 1 of 11
BLISTEX  FOILLE MEDICATED FIRST AID
benzocaine and chloroxylenol ointment
Product Information
Item Code (Source)NDC:10157-9302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
CERESIN (UNII: Q1LS2UJO3A)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CORN OIL (UNII: 8470G57WFM)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
EUGENOL (UNII: 3T8H1794QW)  
MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/05/2013
Part 2 of 11
HYDROCORTISONE 
anti-itch cream
Product Information
Item Code (Source)NDC:0498-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0801-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2019
Part 3 of 11
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:0498-0100-0130 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 4 of 11
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 5 of 11
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 6 of 11
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2018
Part 7 of 11
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 8 of 11
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
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
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 9 of 11
BURN JEL 
gel for burns gel
Product Information
Item Code (Source)NDC:0498-0203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0203-003.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2018
Part 10 of 11
HYDROCORTISONE 
anti-itch cream ointment
Product Information
Item Code (Source)NDC:0498-0800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0800-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/201310/15/2019
Part 11 of 11
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
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 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
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
Blistex Inc.005126354manufacture(10157-9302)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4246)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(0498-0114, 0498-2001)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0221, 0498-0203, 0498-0800, 0498-0801)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0143)
Establishment
NameAddressID/FEIBusiness Operations
Sion Medical Biotext532775194manufacture(0498-0121)

Revised: 10/2019
Document Id: 950f0eb3-76c2-fc25-e053-2a95a90a8beb
Set id: 85f9546e-8747-e3ee-e053-2991aa0a6545
Version: 2
Effective Time: 20191016
 
Honeywell Safety Products USA, INC