4396 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4396

4396 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4396 First Aid Kit is 0498-4396. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4396 First Aid Kit drug includes . The currest status of 4396 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4396
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:	4396 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:	4396 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:	21 Nov, 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:	1012100
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.
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
0498-4396-01	1 KIT in 1 KIT (0498-4396-01) * 10 POUCH in 1 CARTON (0498-0121-34) / .3 mL in 1 POUCH (0498-0121-00) * .9 g in 1 PACKET	21 Nov, 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

4396 First Aid Kit

Kit
Honeywell Safety Products USA, Inc
NDC: 0498-4396

Purpose:

Pvp wipes purpose first aid antiseptic

Burn cream purpose first aid antiseptic external analgesic

Purpose respiratory stimulant

Product Elements:

4396 first aid kit 4396 first aid kit pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine first aid burn benzalkonium chloride, lidocaine hydrochloride glycerin glyceryl monostearate propylparaben propylene glycol aloe vera leaf diazolidinyl urea stearic acid methylparaben peg-100 stearate cetyl alcohol trolamine water edetate disodium edetic acid light mineral oil lidocaine hydrochloride lidocaine lidocaine hydrochloride benzalkonium chloride benzalkonium

Indications and Usage:

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

Burn cream uses prevent skin infection for temporary relief of pain associated with miinor burns

Ammonia uses to prevent or treat fainting

Warnings:

Pvp wipes 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.

Burn cream warnings for external use only do not use in or near the eyes if you are allergic to any of the ingredients in large areas of the body particularly over raw surfaces or blistered areas for more than 10 days ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition persists symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of chidren if swallowed, get medical help or contact a poison control center right away.

Ammonia warnings for external use only do not use if you have breathing problems such as asthma or emphysema stop use and ask a doctor if condition persists keep out of reach of children if swallowed get medical help or contact a poison control center right away.

Do Not Use:

Dosage and Administration:

Pvp wipes 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

Burn cream directions adults and children 2 years of age and older: clean the affected area apply a small amount of this product (equal to the area of the tip of finger) onto the affected area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor

Ammonia directions hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve. hold near nostrils for inhalation of volatile vapor

Stop Use:

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 condition persists symptoms persist for more than 7 days or clear up and occur again within a few days

Stop use and ask a doctor if condition persists

Package Label Principal Display Panel:

Honeywell pvp wipes honeywell pvp wipe

Burn cream principal display panel burn cream

Ammonia principal display panel ammonia inhalent

4396 kit label 011798-1494 4396 label

Further Questions:

Pvp wipes questions 800-430-5490

Burn cream questions 1-800-430-5490

Ammonia 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.