4395 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4395

4395 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4395 First Aid Kit is 0498-4395. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4395 First Aid Kit drug includes . The currest status of 4395 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4395
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	4395 First Aid Kit
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	4395 First Aid Kit
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Honeywell Safety Products Usa, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	18 Oct, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Honeywell Safety Products USA, INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198440 212033 310965 311928 797544 1012100 1038558
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0821812011851 0669635351682
UPC stands for Universal Product Code.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0498-4395-01	1 KIT in 1 KIT (0498-4395-01) * 2 TABLET in 1 PACKET (0498-2110-01) * 2 TABLET in 1 PACKET (0498-7502-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0730-01) * 1.4 mL in 1 PACKET (0498-0501-00) * 2 TABLET in 1 PACKET (0498-0114-01) * .4 mL in 1 POUCH (0498-0143-04)	18 Oct, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

4395 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4395

Purpose:

Alcohol wipe purpose first aid antiseptic

Aspirin purpose pain reliever/fever reducer

Bzk purpose first aid antiseptic

Neomycin purpose first aid antibiotic

Aypanal ex purpose pain reliever/fever reducer

Fabc purpose first aid antiseptic external analgesic

Cedaprin purpose pain reliever/fever reducer

Product Elements:

4395 first aid kit 4395 first aid kit alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol aspirin aspirin cellulose, microcrystalline polyethylene glycol, unspecified stearic acid starch, corn povidone silicon dioxide croscarmellose sodium croscarmellose hypromellose 2208 (100 mpa.s) mineral oil titanium dioxide propylene glycol aspirin aspirin fr21 neomycin antibiotic petrolatum neomycin sulfate neomycin antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium aypanal ex acetaminophen povidone microcrystalline cellulose starch, corn sodium starch glycolate type a potato stearic acid acetaminophen acetaminophen fr1 first aid burn benzalkonium chloride, lidocaine hydrochloride diazolidinyl urea propylene glycol aloe vera leaf cetyl alcohol peg-100 stearate edetate disodium edetic acid trolamine water stearic acid methylparaben glyceryl monostearate light mineral oil glycerin propylparaben benzalkonium chloride benzalkonium lidocaine hydrochloride lidocaine lidocaine hydrochloride cedaprin ibuprofen hypromelloses triacetin povidone k30 silicon dioxide ferric oxide red titanium dioxide sodium starch glycolate type a potato starch, corn lactose monohydrate anhydrous lactose stearic acid ibuprofen ibuprofen g;2

Indications and Usage:

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

Aspirin uses temporarily reduces fever and relieves minor aches and pains associated with: a cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual periods

Bzk uses antiseptic cleansing of face, hands, and body without soap and water

Neomycin uses first aid to help prevent infection in minor cuts scrapes burns do not use in the eyes over large areas of the body

Aypanal ex uses temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever

Fabc uses prevent skin infection for temporary relief of pain associated with minor burns

Cedaprin uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Warnings:

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.

ever/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.

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.

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

Neomycin warnings for external use only ask a doctor before use if you have 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 reach of children if swallowed, get medical help or contact a poison control center right away

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. 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 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 healt Read more...

h professional before use. 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.

Fabc warnings for external use only do not use in or near the eyes if you are allergic to any of the ingredients lin 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 keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

ave 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 when using this product, take with food or milk if stomach upset occurs 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, 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. keep out of reach of children. overdose warning: in case of 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..

Do Not Use:

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 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.

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 when using this product, take with food or milk if stomach upset occurs 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, 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. keep out of reach of children. overdose warning: in case of 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..

When Using:

When using this product do not use longer than one week unless directed by a doctor

When using this product, take with food or milk if stomach upset occurs

Dosage and Administration:

Alcohol wipe directions clean the affected area apply wipe to affected area 1 to 3 times daily may be covered with a sterile bandage discard wipe after single use

Aspirin directions drink a full glass of water with each dose adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours children under 12 years of age: consult a doctor

Bzk directions tear open packet and use as a washcloth

Neomycin directions clean the affected area apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Aypanal ex directions do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 tablets with water every 6 hours while symptoms last. do not take any more than 8 tablets in 24 hours. children under 12: consult a doctor

Fabc direcctions adults and children 2 years of age and older: clean the affected area apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: consult a doctor

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

Stop Use:

Stop use and consult a doctor if condition persists or gets worse

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

Stop use and ask a doctor if if irritation, redness or other symptoms develop the condition persists or gets worse

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

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.

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

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

Spl Patient Package Insert:

Neomycin other information store at 15 0 to 25 0 c (59 0 to 77 0 f)

Package Label Principal Display Panel:

Alcohol wipe label alcohol wipe label

Aspirin principal display panel aspirin

Bzk principal display panel antiseptic towelette

Neomycin principal display panel neomycin

Aypanal ex principal display panel aypanalex label

Fabc principal display panel first aid burn cream

Cedaprin principal display panel cedaprin

4395 kit label z019840 4395 label

Further Questions:

Alcohol wipe questions 1-800-430-5490

Aspirin questions or comments 1-800-430-5490

Bzk questions 1-800-430-5490

Neomycin questions 1-800-430-5490

Aypanal ex questions or comments? 1-800-430-5490

Fabc questions 1-800-430-5490

Cedaprin questions or comments? 1-800-430-5490

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.