4349 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4349

4349 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4349 First Aid Kit is 0498-4349. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4349 First Aid Kit drug includes . The currest status of 4349 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4349
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:	4349 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:	4349 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 Jun, 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:	311928 1039012 1043690 1053173 1440184
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 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
0498-4349-01	1 KIT in 1 KIT (0498-4349-01) * 59 mL in 1 BOTTLE, SPRAY (0498-0402-59) * .9 g in 1 PACKET (0498-0800-35) * .9 g in 1 PACKET (0498-0730-01) * .9 g in 1 PACKET (0498-0801-35) * 59 mL in 1 BOTTLE, SPRAY (0498-0221-59) * .3 mL in 1 POUCH (0498-0121-00) * 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

4349 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4349

Purpose:

Eyesaline purpose eyewash

Povidone iodine swab purpose first aid antiseptic

Neomycin purpose first aid antibiotic

Antiseptic spray purpose first aid antiseptic

Burn spray purpose benzethonium chloride 0.2% w/w benzocaine 10% w/w menthol 0.33% w/w

Hydrocortisone purpose anti-itch cream

Product Elements:

4349 first aid kit 4349 first aid kit eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine burn relief lidocaine hydrochloride edetate disodium edetic acid glycerin trolamine propylparaben propylene glycol water octoxynol-9 hypromelloses tea tree oil methylparaben diazolidinyl urea lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous antiseptic benzalkonium chloride water octoxynol 9 glycerin diazolidinyl urea dipropylene glycol edetate disodium edetic acid trolamine methylparaben propylparaben hypromellose, unspecified benzalkonium chloride benzalkonium neomycin antibiotic petrolatum neomycin sulfate neomycin hydrocortisone anti-itch cream citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone hydrocortisone anti-itch citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone 4352 first aid kit 4352 first aid kit eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine burn relief lidocaine hydrochloride edetate disodium edetic acid glycerin trolamine propylparaben propylene glycol water octoxynol-9 hypromelloses tea tree oil methylparaben diazolidinyl urea lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous antiseptic benzalkonium chloride water octoxynol 9 glycerin diazolidinyl urea dipropylene glycol edetate disodium edetic acid trolamine methylparaben propylparaben hypromellose, unspecified benzalkonium chloride benzalkonium neomycin antibiotic petrolatum neomycin sulfate neomycin hydrocortisone anti-itch cream citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone hydrocortisone anti-itch citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone 4371 first aid kit 4371 first aid kit eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine burn relief lidocaine hydrochloride edetate disodium edetic acid glycerin trolamine propylparaben propylene glycol water octoxynol-9 hypromelloses tea tree oil methylparaben diazolidinyl urea lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous antiseptic benzalkonium chloride water octoxynol 9 glycerin diazolidinyl urea dipropylene glycol edetate disodium edetic acid trolamine methylparaben propylparaben hypromellose, unspecified benzalkonium chloride benzalkonium neomycin antibiotic petrolatum neomycin sulfate neomycin hydrocortisone anti-itch cream citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone hydrocortisone anti-itch citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone 4374 first aid kit 4374 first aid kit eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine burn relief lidocaine hydrochloride edetate disodium edetic acid glycerin trolamine propylparaben propylene glycol water octoxynol-9 hypromelloses tea tree oil methylparaben diazolidinyl urea lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous antiseptic benzalkonium chloride water octoxynol 9 glycerin diazolidinyl urea dipropylene glycol edetate disodium edetic acid trolamine methylparaben propylparaben hypromellose, unspecified benzalkonium chloride benzalkonium neomycin antibiotic petrolatum neomycin sulfate neomycin hydrocortisone anti-itch cream citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid propylene glycol hydrocortisone acetate hydrocortisone hydrocortisone anti-itch propylene glycol hydrocortisone acetate hydrocortisone citric acid monohydrate edetate disodium edetic acid glyceryl monostearate cetyl alcohol trolamine methylparaben diazolidinyl urea glycerin water polyethylene glycol, unspecified propylparaben light mineral oil stearic acid

Indications and Usage:

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

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

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

Antiseptic spray uses first aid to help prevent infection in minor cuts, scrapes and burns

Burn spray uses for the temporary relief of pain and itching and helps protect against infection in: minor cuts and scrapes burns sunburn insect bites minor skin irritations

Hydrocortisone uses for the temporary relief of itching associated with minor skin irritations and rashes

Warnings:

Eyesaline 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.

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

Neomycin 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 burns stop use and ask a doctor if a rash or other allergic reaction develops you need to use longer than 1 week 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 do not use in the eyes over large areas of the body

Antiseptic spray warnings for external use only do not use in or near the eyes over large areas of the body 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 week unless directed by a doctor stop use and ask a doctor if 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

Burn spray warnings for external use only flammable keep away from fire or flame contents under pressure do not puncture or incinerate container do not expose to temperatures above 120 0 f do not use in or near the eyes or other mucous membranes in case of serious burns in case of deep or puncture wounds for prolonged period of time on large portion of the body stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days condition clears up and recurs within a few days redness, swelling, or irritation occurs keep out of the reach of children if swallowed, get medical help or contact a poison control center right away.

Hydrocortisone warnings for external use only ask a doctor before use if you are using any other hydrocortisone product when using the product avoid contact with eyes do not begin use of any other hydrocortisone product unless you have consulted a doctor do not use for the treatment of diaper rash stop use and ask a doctor if condition worsens condition persists 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.

Do Not Use:

When Using:

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

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

When using the product avoid contact with eyes do not begin use of any other hydrocortisone product unless you have consulted a doctor do not use for the treatment of diaper rash

Dosage and Administration:

Eyesaline 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

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

Neomycin direction 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

Antiseptic spray directions clean the affected area spray a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Burn spray directions clean the affected area shake can well before using hold 4 - 6 inches from surface and spray area until wet may be covered with a sterile bandage, if bandaged let dry first for adult institutional use only not intended for use on children

Hydrocortisone directions adults and children 2 years and older: clean the affected area apply to the area not more than 3 to 4 times daily children under 2 years of age: consult 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 conditions persists or gets worse irritation and redness develops

Stop use and ask a doctor if a rash or other allergic reaction develops you need to use longer than 1 week

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 the condition persists or gets worse

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days condition clears up and recurs within a few days redness, swelling, or irritation occurs

Stop use and ask a doctor if condition worsens condition persists for more than 7 days condition clears up and recurs within a few days

Package Label Principal Display Panel:

Eyesaline principal display panel eyesaline

Povidone iodine swab principal display panel pvp swab

Neomycin principal display panel neomycin

Antiseptic spray principal display panel antiseptic spray

Burn spray principal display panel burn spray

Hydrocortisone principal display panel hydrocortisone

4349 kit label 0198500-4222 4349 label

4349 kit contnets 018500-4222 1 1 x 3 woven 100/box 1 neomycin antibiotic 10 per 1 triangular bdg, non-sterile 1 wire splint 1 per 1 rescue blanket 1 per 1 gauze comp, 18" x 36", 2 per 1 bandage comp, 2" offset, 4 per 1 hydrocortison,1.o%,1/32 oz,10p 1 tweezer plastics 4" 4 o/h pak,adh bdg 2"x4", x-lg 1 o/h pump antiseptic 2 oz id f 1 o/h pump burn relief 2 oz id g 1 first aid guide ashi 1 tape adhesive 1"x 5 yd plstc 2 gauze clean-wrap bdge n/s 2" 1 abd combine pad 5" x 9" 1 gze pads sterile 3"x 3" 10's 10 pvp prep pads medium 1 4oz bfs eyewash trilingual bottle 1 scissor bdge 4" red pls hdl lbl stock 6-3/8"x4" lbl stock 4"x2-7/8" 1 lbl stock 3"x1-7/8" 2 pr lrg nitrile glves zip bag 2 tape adhesive 1/2 x 2.5 125133 1 self-adh wrap 3 x 5 yds north rev e 1 kit bag soft pack large 1 lbl contents ansi z308.1-2009 rev b 2 cold pack unit 4"x6" bulk 4 eye pads std oval sterile 4 woven fingertip bandage 2" 6 woven knuckle bandage

4352 kit label 018504-4222 4352 label

4371 kit label z018500-4222 4371 label

Further Questions:

Eyesaline questions 1-800-430-5490 honeywell sadety products usa, inc. smithfield, ri 02917

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

Neomycin questions? 1-800-430-5490

Antiseptic spray questions 1-800-430-5490

Hydrocortisone 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.