4346 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4346

4346 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4346 First Aid Kit is 0498-4346. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4346 First Aid Kit drug includes . The currest status of 4346 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4346
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:	4346 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:	4346 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:	14 May, 2026
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:	198529 204602 359221 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:	0364809450337 0821812014999
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
0498-4346-01	1 KIT in 1 KIT (0498-4346-01) * .9 g in 1 PACKET (0498-0750-35) * 1.4 mL in 1 PACKET (0498-0501-00) * 2 TABLET in 1 PACKET * 2 TABLET in 1 PACKET (0498-2422-01) * 59 mL in 1 BOTTLE, SPRAY (0498-0221-59) * 118 mL in 1 BOTTLE (0498-0100-02)	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

4346 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4346

Purpose:

Eyewash purpose eyewash

Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic

Miralac purpose antacid

Bzk purpose first aid antiseptic

Pain stopper purpose pain reliever/fever reducer pain reliever/fever reducer diuretic pain reliever/fever reducer

Burn relief wj purpose external analgesic

Product Elements:

4346 first aid kit 4346 first aid kit eyesaline emergency eyewash purified water sodium phosphate, monobasic, monohydrate sodium chloride sodium phosphate, dibasic water water burn relief lidocaine hydrochloride glycerin edetate disodium edetic acid diazolidinyl urea trolamine propylparaben methylparaben hypromelloses octoxynol-9 water tea tree oil lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin miralac calcium carbonate magnesium stearate silicon dioxide sorbitol starch, corn calcium carbonate calcium cation carbonate ion fr8 antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium pain stoppers acetaminophen, caffeine, aspirin, salicylamide caffeine caffeine salicylamide salicylamide aspirin aspirin magnesium stearate cellulose, microcrystalline stearic acid povidone k30 fd&c yellow no. 6 food yellow 3 free acid acetaminophen acetaminophen bright orange fr;2

Indications and Usage:

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

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

Miralac uses for the relief of acid indigestion heartburn sour stomach upset stomach associated with these symptoms

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

Pain stopper uses for the temporary relief of minor aches and pains due to: â¢ common cold â¢ headache â¢ muscular aches â¢ premenstrual and menstrual cramps

Burn relief wj uses temporarily relieves pain due to minor burns

Warnings:

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.

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.

Warnings ask a doctor before use if you have kidney stones calcium-restricted diet ask a doctor before use if you are presently taking a prescription drug. antacids may interfere with certain prescription drugs when using this product do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. keep out of the reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center immediately.

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

vere 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pin that does not get better if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product. if pregnant or breast-feeding ask a healthcare professional before use. it is especially important not to use aspirin 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 pregnancy. 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 children even if you do not notice any signs or symptoms.

Burn relief wj 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.

Do Not Use:

Pain stopper 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 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. liver warning : this product contains acetaminophen. severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pin that does not get better if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product. if pregnant or breast-feeding ask a healthcare professional before use. it is especially important not to use aspirin 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 pregnancy. 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 children even if you do not notice any signs or symptoms.

When Using:

When using this product do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

When using this product avoid contact with the eyes

Dosage and Administration:

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

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

Miralac directions chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.

Bzk directions tear open packet and use as a washcloth

Pain stopper directions adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist do not take more than 12 tablets in 24 hours children under 12 years: consult a doctor

Burn relief wj directions adults and children 2 years of age and olde r: apply to affected area not more than 3 to 4 times daily children under 2 years of age : ask a doctor

Stop Use:

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

Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pin that does not get better if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.

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

Package Label Principal Display Panel:

Eyewash principal display panel eyesaline

Triple principal display panel triple antibiotic

Miralac principal display panel miralac

Bzk principal display panel antiseptic wipe

Pain stopper principal display panel pain stoppers

Burn relieff wj principal display panel burn relief label

4346 kit label z68140grr 4346 label

Further Questions:

Eyewash questions 1-800-430-5490

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

Bzk questions 1-800-430-5490

Questions or comments? 1-800-430-5490

Pain stopper questions or comments? 1-800-430-5490

Burn relief wj 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.