Label: 4389 FIRST AID KIT kit
-
NDC Code(s):
0498-0100-02,
0498-0114-01,
0498-0203-00,
0498-0501-00, view more0498-0750-35, 0498-2110-01, 0498-3334-00, 0498-4389-01, 0498-7502-01
- Packager: Honeywell Safety Products USA, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Eyewash Active ingredient
- Eyewash Purpose
- 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.
- Eyewash Directions
- Eyewash Inactive ingredients
- Eyewash Questions
- Aspirin Active ingredient (in each tablet)
- Aspirin Purpose
- Aspirin Uses
-
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:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are:
- age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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.
- Aspirin Directions
- Aspirin Other information
- Aspirin Inactive ingredients
- Aspirin Questions or Comments
- Ammonia Active ingredient
- Ammonia Purpose
- Ammonia Uses
- Ammonia Warnings
- Ammonia Directions
- Ammonia Other information
- Ammonia Inactive ingredient
- Ammonia Questions or Comments?
- BZK Active ingredient
- BZK Purpose
- BZK Uses
-
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
- BZK Directions
- BZK Other information
- BZK Inactiave ingredient
- BzK Questions
- Cedaprin Active ingredient
- Cedaprin Purpose
- Cedaprin Uses
-
Cedaprin
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Heart attack and stroke warning:
- NSAID's, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- you have problems or serious side effectsfrom taking pain relievers or fever reducers
- 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, kidney disease, asthma or had a stroke
- you are taking a diuretic
Ask a doctor or a pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirin
- under a doctors care for any serious condition
- taking any other drug
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
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in oe part or side of body
- slurred speech
- leg swelling
- 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
- any new symptoms appear​
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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 delivery.
-
Cedaprin
Directions
- do not take more than directed
- the smallest effective dose should be used
- adult and children 12 years of age and over:
- take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- Cedaprin Other information
- Cedaprin Inactive ingredients
- Questions or Comments?
- Burn Jel Active ingredient
- Burn Jel Purpoose
- Burn Jel Uses
- Burn Jel Warnings
- Burn Jel Directions
- Burn Jel Other information
- Burn Jel Inactive ingredients
- Burn Jel Questions
- Triple Active ingredients
- Triple Purpose
- Triple Uses
-
Triple
Warnings
For external use only
Allergy alert do not use if you are allergic to any of the ingredients
Ask a doctor before use if you have
- a deep or puncture wounds
- animal bites
- serious burnsnot use if you are allergic to any of the ingredients
- Triple Directions
- Triple Other information
- Triple Inactive ingredient
- Triple Questions?
- Aypanal Active ingredient (in each tablet)
- Aypanal Ex Purpose
- Aypanal Ex Uses
-
Aypanal Ex
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount.
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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.
- Aypanal Ex Directions
- Aypanal Ex Other information
- Aypanal Ex Inactive ingredients
- Aypanal Ex Questions or Comments?
-
4389
68P24AG KIT CONTENTS
1 TRIANGULAR BDG, NON-STERILE
3 INSTANT COLD PACK 4" X 6"
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 BURN JEL 1/8 OZ, 6 PER
1 NITRILE GLOVES 2PR BBP
1 ANTIMCRBL ANTSPTC TWLETTS
1 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 BANDAGE COMP 4" W/TELFA PAD 1
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 TRIPLE BIOTIC 12 PER ZIP BAG
1 CEDAPRIN 12 PACK PER ZIP BAG
1 aspirin12 PACK PER ZIP BAG
1 KIT PP 24 UNIT FA
1 ADHS TAPE .5"X2.5YD 2
1 GAUZE PADS 3"X3" 4/BX
3 AMMONIA INHALANT, BULK
- Eyewash Principal Display Panel
- Aspirin Principal Display Panel
- Ammonia Principal Display Panel
- BZK Principal Display Panel
- Cedaprin Principal Display Panel
- Burn Jel Principal Display Panel
- Triple Principal Display Panel
- Aypanal EX Principal Display Panel
- 4389 Kit Label 68P24AG
-
INGREDIENTS AND APPEARANCE
4389 FIRST AID KITÂ
4389 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4389 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4389-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 12 PACKET 24 Part 3 3 AMPULE 0.9 mL Part 4 1 PACKET 1.4 mL Part 5 12 PACKET 24 Part 6 12 PACKET 24 Part 7 12 PACKET 10.8 g Part 8 6 PACKET 21 g Part 1 of 8 EYESALINE EMERGENCY EYEWASHÂ
purified water liquidProduct Information Item Code (Source) NDC:0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL  in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 8 ASPIRINÂ
aspirin tabletProduct Information Item Code (Source) NDC:0498-0114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/18/2018 Part 3 of 8 AMMONIA INHALENTÂ
ammonia inhalent inhalantProduct Information Item Code (Source) NDC:0498-3334 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g  in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/18/2018 Part 4 of 8 ANTISEPTIC TOWELETTEÂ
benzalkonium chloride liquidProduct Information Item Code (Source) NDC:0498-0501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0501-00 1.4 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/22/2017 Part 5 of 8 AYPANAL EXÂ
acetaminophen tabletProduct Information Item Code (Source) NDC:0498-2110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  POVIDONE (UNII: FZ989GH94E)  SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code FR1 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-2110-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/02/2017 Part 6 of 8 CEDAPRINÂ
ibuprofen tabletProduct Information Item Code (Source) NDC:0498-7502 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  HYPROMELLOSES (UNII: 3NXW29V3WO)  STEARIC ACID (UNII: 4ELV7Z65AP)  LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  FERRIC OXIDE RED (UNII: 1K09F3G675)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  TRIACETIN (UNII: XHX3C3X673)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  POVIDONE K30 (UNII: U725QWY32X)  Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-7502-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079129 01/02/2017 Part 7 of 8 TRIPLE ANTIBIOTICÂ
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Item Code (Source) NDC:0498-0750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U)  Product Characteristics Color white Score     Shape Size Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0750-35 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/19/2018 Part 8 of 8 BURN JELÂ
gel for burns gelProduct Information Item Code (Source) NDC:0498-0203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g  in 100 g Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40)  GLYCERIN (UNII: PDC6A3C0OX)  EDETATE DISODIUM (UNII: 7FLD91C86K)  TEA TREE OIL (UNII: VIF565UC2G)  DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  TROLAMINE (UNII: 9O3K93S3TK)  METHYLPARABEN (UNII: A2I8C7HI9T)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0203-00 3.5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321)