4357 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4357

4357 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4357 First Aid Kit is 0498-4357. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4357 First Aid Kit drug includes . The currest status of 4357 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4357
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:	4357 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:	4357 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:	199005 204602 213034 797544 1011852 1043690 1053173 1192516 1440184 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:	0669635150759 0364809450337 0041388003023
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
0498-4357-01	1 KIT in 1 KIT (0498-4357-01) * .5 g in 1 PACKET (0498-0750-36) * 14 g in 1 TUBE * .9 g in 1 PACKET (0498-0800-35) * .4 mL in 1 POUCH (0498-0143-04) * 3.5 g in 1 PACKET (0498-0203-00) * 85 g in 1 CAN (0498-0021-40) * .9 g in 1 PACKET (0498-0801-35) * 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

4357 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4357

Purpose:

Eyewash purpose eyewash

Burn relief water soluble purpose topical antiseptic topical anesthetic topical anesthetic

Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic

Alcohol purpose first aid antiseptic

Hyrdocortisone purpose anti-itch cream

Foille purpose external analgesic antiseptic

Burn jel purpose external analgesic

Product Elements:

4357 first aid kit 4357 first aid kit hydrocortisone anti-itch stearic acid trolamine methylparaben water edetate disodium edetic acid light mineral oil propylene glycol diazolidinyl urea propylparaben glycerin citric acid monohydrate glyceryl monostearate polyethylene glycol, unspecified cetyl alcohol hydrocortisone acetate hydrocortisone eyesaline emergency eyewash purified water sodium phosphate, monobasic, monohydrate sodium chloride sodium phosphate, dibasic water water burn water soluble benzocaine, benzethonium chloride, menthol isobutane butane propane dipropylene glycol benzethonium chloride benzethonium benzocaine benzocaine menthol menthol triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol hydrocortisone anti-itch cream stearic acid trolamine methylparaben water edetate disodium edetic acid light mineral oil propylene glycol diazolidinyl urea propylparaben glycerin citric acid monohydrate glyceryl monostearate polyethylene glycol, unspecified cetyl alcohol hydrocortisone acetate hydrocortisone blistex foille medicated first aid benzocaine and chloroxylenol sodium lauryl sulfate benzyl alcohol edetate calcium disodium anhydrous calcium cation ceresin eugenol maleic anhydride polyethylene glycol 1500 corn oil sodium borate yellow wax calcium hydroxide water benzocaine benzocaine chloroxylenol chloroxylenol burn jel gel for burns trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) propylparaben octoxynol-9 tea tree oil diazolidinyl urea edetate disodium edetic acid dipropylene glycol glycerin methylparaben lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous

Indications and Usage:

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

Burn relief water soluble 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

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

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

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

Foille uses for the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. first aid to help prevent infection in minor cuts, scrapes and burns.

Burn jel 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.

Burn relief water soluble 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.

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.

Alcohol warnings for external use only flammable, keep away from fire or flame. 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 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.

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

Foille warnings for external use only when using this product avoid contact with the eyes stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Burn jel warnings for external use oonly 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.

Do Not Use:

When Using:

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

When using this product avoid contact with the eyes

When using this product avoid contact with 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

Burn relief water soluble 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

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

Alcohol 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

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

Foille directions clean the affected area. 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: consult a physician.

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

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 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 the condition persists or gets worse a rash or other allergic reaction develops you need to use longer than 1 week

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

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

Stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

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

Package Label Principal Display Panel:

Eyewash principal display panel eyesaline

Burn relief water soluble principal display panel burn ws label

Triple principal display panel triple antibiotic

Alcohol principal display panel alcohol preps

Hydrocortisone principal display panel hydrocortisone

Foille principal display panel foille

Burn jel principal display panel burn jel

4357 kit label 6832649 4357 label

Further Questions:

Eyewash questions 1-800-430-5490

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

Burn jel 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.