4364 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4364

4364 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4364 First Aid Kit is 0498-4364. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4364 First Aid Kit drug includes . The currest status of 4364 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4364
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:	4364 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:	4364 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:	25 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:	204602 313782 1011852 1038558 1190560 2056934
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:	0669635351705 0669635351019
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
0498-4364-01	1 KIT in 1 KIT (0498-4364-01) * .9 g in 1 PACKET (0498-0750-35) * 3.5 g in 1 PACKET (0498-0203-00) * .3 mL in 1 POUCH (0498-0121-00) * 2 TABLET in 1 PACKET * .4 mL in 1 POUCH (0498-0733-00) * 1.4 mL in 1 PACKET (0498-0501-00)	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

4364 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4364

Purpose:

Burn jel purpose external analgesic

Povidone iodine swab purpose first aid antiseptic

Aypanal purpose pain reliever/ fever reducer

Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic

Sting relief purpose antiseptic topical pain relief

Bzk purpose first aid antiseptic

Product Elements:

4364 first aid kit 4364 first aid kit antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium sting relief pad ethyl alcohol, lidocaine benzalkonium chloride menthol water alcohol alcohol lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum bacitracin zinc bacitracin polymyxin b sulfate polymyxin b neomycin sulfate neomycin pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine burn jel gel for burns trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) diazolidinyl urea edetate disodium edetic acid propylparaben octoxynol-9 dipropylene glycol tea tree oil glycerin methylparaben lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous aypanal non-aspirin acetaminophen starch, corn stearic acid povidone sodium starch glycolate type a corn acetaminophen acetaminophen circle;u

Indications and Usage:

Burn jel uses temporarily relieves pain due to minor burns

Povidone iodine swab uses first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

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

Triple uses first aid to help prevent infection in minor cuts scrapes burns

Sting relief uses prevent infection in minor scrapes, and temporary relief of itching of insect bites

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

Warnings:

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 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 keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Povidone iodine swab warnings for external use only do not use 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 stop use and ask a doctor if conditions persists or gets worse irritation and redness develops keep out of reach of children if swallowed, get medical help or contact a poison control center right away

n 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. keep out of reach of children. keep out of reach of children.

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 ask a doctor before use if you have a 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 the reach of children if swallowed, get medical help or contact a poison control center right away.

Sting relief warnings for external use only flammable, keep away from open fire or flame do not use over large areas of the body in eyes over raw or blistered areas stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days keep out of reach of children. if swallowed, get medical help or contact a 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:

Aypanal 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 child takes more than 5 doses in 24 hours, which is the maximum daily amount taken 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 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 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. keep out of reach of children. keep out of reach of children.

When Using:

When using this product avoid contact with eyes

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

Dosage and Administration:

Burn jel 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 you may report a serious reaction to this product to 800-430-5490

Povidone iodine swab directions reverse cardboard sleeve, then crush at dot between thumb and forefinger. allow solution to saturate tip and apply solution to injury. clean affected area apply to affected area 1 to 3 times daily may be covered with a sterile bandage discard swab after single use

Aypanal directions do not take more than directed (see overdose warning) âadults and children 12 years of age or older take two tablets every 4-6 hours while symptoms last do not take more than 12 tablets in 24 hours children 6 to under 12 years of age take 1 tablet every 4-6 hours while symptoms last do not take more than 5 tablets in 24 hours children under 6 years consult a doctor

Triple 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

Sting relief directions adults and children 2 years and older: apply to cleaned affected area not more than 3 times daily. children under 2 years of age: consult a doctor.

Bzk directions tear open packet and use as a washcloth

Stop Use:

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

Stop use and ask a doctor if conditions persists or gets worse irritation and redness develops

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

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 conditions worsen or persist for more than 7 days or clear up and occur again within a few days

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

Overdosage:

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.

Package Label Principal Display Panel:

Burn jel principal display panel burn jel

Povidone iodine swab principal display panel pvp swab

Aypanal principal display panel aypanal

Triple principal display panel triple antibiotic

Sting relief principal display panel sting relief

Bzk principal display panel antiseptic towelette

4364 kit label sf00003201 4364 label

Further Questions:

Burn jel questions 1-800-430-5490

Povidone iodine swab questions and comments 1-800-430-5490

Aypanal questions 1-800-430-5490

Triple questions? 1-800-430-5490

Sting relief questions or comments? 1-800-430-5490

Bzk questions 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.