4401 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4401

4401 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4401 First Aid Kit is 0498-4401. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4401 First Aid Kit drug includes . The currest status of 4401 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4401
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:	4401 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:	4401 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:	14 Mar, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	08 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:	1190560 1299889
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
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
0498-4401-01	1 KIT in 1 KIT (0498-4401-01) * .4 mL in 1 POUCH (0498-0733-00) * .3 mL in 1 AMPULE (0498-3334-00) * .3 mL in 1 POUCH (0498-0121-00)	14 Mar, 2019	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

4401 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4401

Purpose:

Ammonia inhalent purpose respiratory stimulant

Pvp purpose first aid antiseptic

Sting relief purpose antiseptic topical pain relief

Product Elements:

4270 first aid kit 4270 first aid kit ammonia inhalent ammonia inhalent alcohol ammonia ammonia pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine sting relief pad ethyl alcohol, lidocaine menthol water benzalkonium chloride lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol 4401 first aid kit 4401 first aid kit ammonia inhalent ammonia inhalent alcohol ammonia ammonia pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine sting relief pad ethyl alcohol, lidocaine menthol water benzalkonium chloride lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol

Indications and Usage:

Ammonia inhalent uses to prevent or treat fainting

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

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

Warnings:

Ammonia inhalent 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.

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

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.

Do Not Use:

When Using:

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

Dosage and Administration:

Ammonia inhalent 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

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

Stig 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.

Stop Use:

Stop use and ask a doctor if condition persists

Stop use and ask a doctor if conditions persists or gets worse irritation and redness develops

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

Package Label Principal Display Panel:

Ammonia inahalent principal display panel ammonia inhalent

Pvp principal display panel pvp swab

Sting relief principal display panel sting relief

4270 kit label sf00001090 4270 label

4401 kit label sf00001103 4401 label

Further Questions:

Ammonia inhalent questions 1-800-430-5490

Pvp questions 1-800-430-5490

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.