4318 First Aid Kit

4318 First Aid

Honeywell Safety Products Usa, Inc.
Human Otc Drug
NDC 0498-4318

4318 First Aid Kit also known as 4318 First Aid is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc.'. National Drug Code (NDC) number for 4318 First Aid Kit is 0498-4318. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4318 First Aid Kit drug includes . The currest status of 4318 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4318
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:	4318 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:	4318 First Aid
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:	13 Sep, 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:	204602 1011852 1038558 1043690 1053173 1190560 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:	0364809450337 0821812012841
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
0498-4318-01	1 KIT in 1 KIT (0498-4318-01) * .9 g in 1 PACKET (0498-0750-35) * .9 g in 1 PACKET * .4 mL in 1 POUCH (0498-0733-00) * 1.4 mL in 1 PACKET (0498-0501-00) * .3 mL in 1 POUCH (0498-0121-00) * 30 mL in 1 BOTTLE (0498-0100-01) * 3.5 g in 1 PACKET (0498-0203-00) * .9 g in 1 PACKET	13 Sep, 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

4318 First Aid Kit

4318 First Aid

Kit
Honeywell Safety Products USA, Inc.
NDC: 0498-4318

Purpose:

Burn jel purpose external analgesic

Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic

Sting relief purposse antiseptic topical pain relief

Eyewassh purpose eyewash

Hydrcortisone purpose anti-itch cream

Pvp purpose first aid antiseptic

Bzk purpose first aid antiseptic

Product Elements:

4318 first aid kit 4318 first aid hydrocortisone anti-itch light mineral oil polyethylene glycol, unspecified cetyl alcohol methylparaben propylene glycol edetate disodium edetic acid stearic acid glyceryl monostearate trolamine diazolidinyl urea propylparaben water glycerin citric acid monohydrate hydrocortisone acetate hydrocortisone burn jel gel for burns tea tree oil diazolidinyl urea methylparaben edetate disodium edetic acid glycerin trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) propylparaben octoxynol-9 dipropylene glycol lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous eyesaline emergency eyewash purified water sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate sodium chloride water water triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium sting relief pad ethyl alcohol, lidocaine benzalkonium chloride menthol water lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol hydrocortisone anti-itch cream light mineral oil polyethylene glycol, unspecified cetyl alcohol methylparaben propylene glycol edetate disodium edetic acid stearic acid glyceryl monostearate trolamine diazolidinyl urea propylparaben water glycerin citric acid monohydrate hydrocortisone acetate hydrocortisone pvp iodine wipe povidone-iodine 10% water nonoxynol-9 povidone-iodine iodine 4319 first aid kit 4319 first aid hydrocortisone anti-itch light mineral oil polyethylene glycol, unspecified cetyl alcohol methylparaben propylene glycol edetate disodium edetic acid stearic acid glyceryl monostearate trolamine diazolidinyl urea propylparaben water glycerin citric acid monohydrate hydrocortisone acetate hydrocortisone burn jel gel for burns tea tree oil diazolidinyl urea methylparaben edetate disodium edetic acid glycerin trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) propylparaben octoxynol-9 dipropylene glycol lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous eyesaline emergency eyewash purified water sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate sodium chloride water water triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium sting relief pad ethyl alcohol, lidocaine benzalkonium chloride menthol water lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol hydrocortisone anti-itch cream light mineral oil polyethylene glycol, unspecified cetyl alcohol methylparaben propylene glycol edetate disodium edetic acid stearic acid glyceryl monostearate trolamine diazolidinyl urea propylparaben water glycerin citric acid monohydrate hydrocortisone acetate hydrocortisone pvp iodine wipe povidone-iodine 10% water nonoxynol-9 povidone-iodine iodine

Indications and Usage:

Burn jel uses temporarily relieves pain due to minor burns

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

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

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

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

Bzk uses antiseptic cleansing of face, hands, and body without soap and water keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

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.

Triple warnings for external use only allergy aler t: 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.

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.

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.

Pvp warnings for external use only. 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 or persists for more than 72 hours irritation and redness develops 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

Do Not Use:

When Using:

When using this product avoid contact with eyes

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:

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

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.

Eyeash 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

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

Pvp directions clean the affected area apply1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first discard wipe after single use

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 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 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 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 persists for more than 72 hours irritation and redness develops

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

Package Label Principal Display Panel:

Burn jel principal display panel burn jel

Triple principal display panel triple antibiotic

Sting relief principal display panel sting relief

Eyewash principal display panel eyesaline

Hydrocortisone principal display panel hydrocortisone cream

Pvp principal display panel pvp wipe

Bzk principal display panel antiseptic towelette

4318 kit label sf00004559 4318 label

4319 kit label sf00004560 4319 label

Further Questions:

Burn jel questions 1-800-430-5490

Triple questions? 1-800-430-5490

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

Eyeash questions call 1-800-430-5490 honeywell safety products usa, inc. smithfield, ri 02917

Hydrocortisone 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.