4195 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4195

4195 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4195 First Aid Kit is 0498-4195. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4195 First Aid Kit drug includes . The currest status of 4195 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4195
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:	4195 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:	4195 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:	06 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:	311928 1053173 1190560
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:	0669635351019 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
0498-4195-01	1 KIT in 1 KIT (0498-4195-01) * 30 mL in 1 BOTTLE (0498-0100-01) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0730-01) * .3 mL in 1 POUCH (0498-0121-00)	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

4195 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4195

Purpose:

Sting relief purpose antiseptic topical pain relief

Neomycin antibiotic ointment purpose first aid antibiotic

Eyewash purpose eyewash

Pvp purpose first aid antiseptic

Product Elements:

4195 first aid kit 4195 first aid kit pvp iodine wipe povidone-iodine 10% water nonoxynol-9 povidone-iodine iodine eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water sting relief pad ethyl alcohol, lidocaine benzalkonium chloride menthol water lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol neomycin antibiotic petrolatum neomycin sulfate neomycin

Indications and Usage:

Sting relief uses prevent infection in minor scrapes, and temporary relief of itching of insect bites

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

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

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

Warnings:

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

Neomycin antibiotic ointment 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 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

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.

Pvp warnings for external use only do not use in the eyes 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

Do Not Use:

When Using:

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

Dosage and Administration:

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.

Neomycin antibiotic ointment 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

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

Pvp 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

Stop Use:

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 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 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

Package Label Principal Display Panel:

Sting relief principal display panel sting relief

Neomycin antibiotic ointment principal display panel neomycin

Eyewash principal display panel eyesaline

Pvp principal display panel pvp swab

4195 kit label 011597-1725 4195 label

Further Questions:

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

Neomycin antibiotic ointment questions 1-800-430-5490

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

Pvp questions and 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.