4134 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4134

4134 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4134 First Aid Kit is 0498-4134. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4134 First Aid Kit drug includes . The currest status of 4134 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4134
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:	4134 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:	4134 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:	212033 1012100 1038558 1053173
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:	0669635351682 0364809450337
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
0498-4134-01	1 KIT in 1 KIT (0498-4134-01) * 30 mL in 1 BOTTLE (0498-0100-01) * 1.4 mL in 1 PACKET (0498-0501-00) * 2 TABLET in 1 PACKET (0498-0114-01) * .9 g in 1 PACKET	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

4134 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4134

Purpose:

First aid burn cream purpose first aid antiseptic external analgesic

Eyewash purpose eyewash

Aspirin purpose pain reliever/fever reducer

Bzk purpose first aid antiseptic

Product Elements:

4134 first aid kit 4134 first aid kit first aid burn benzalkonium chloride, lidocaine hydrochloride propylene glycol aloe vera leaf water stearic acid methylparaben cetyl alcohol glyceryl monostearate peg-100 stearate light mineral oil edetate disodium edetic acid trolamine glycerin propylparaben diazolidinyl urea benzalkonium chloride benzalkonium lidocaine hydrochloride lidocaine lidocaine hydrochloride eyesaline emergency eyewash purified water sodium phosphate, monobasic, monohydrate sodium chloride sodium phosphate, dibasic water water antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium 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

Indications and Usage:

First aid burn cream uses prevent skin infection for temporary relief of pain associated with minor burns

Eyewash uses for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

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

Warnings:

First aid burn cream warnings for external use only do not use in or near the eyes if you are allergic to any of the ingredients in 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

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.

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 keep out of reach of children if swallowed, get medical help or contact a poison control center right away. stop use and ask a doctor if irritation, redness or other symptoms develop the condition persists or gets worse

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.

Dosage and Administration:

First aid burn cream directions 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

Eyewash directions remove contacts before using twist top to remove flush the affected area as needed control rate of flow by pressure on the bottle if necessary, continue flushing with emergency eyewash or shower

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

Stop 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 eye pain changes in vision continued redness or irritation of the eye condition worsens or persists

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 irritation, redness or other symptoms develop the condition persists or gets worse

Package Label Principal Display Panel:

First aid burn cream principal display panel first aid burn cream

Eyewash principal display panel eyewash label

Aspirin principal display panel aspirin

Bzk principal display panel antiseptic wipe

4134 kit label sf00004169 4134 label

Further Questions:

First aid burn cream questions 1-800-430-5490

Eyewash questions 1-800-430-5490

Aspirin 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.