4312 First Aid Kit

Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4312

4312 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4312 First Aid Kit is 0498-4312. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4312 First Aid Kit drug includes . The currest status of 4312 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4312
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:	4312 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:	4312 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:	25 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:	797544 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:	0669635150759 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
0498-4312-01	1 KIT in 1 KIT (0498-4312-01) * 30 mL in 1 BOTTLE (0498-0100-01) * .4 mL in 1 POUCH (0498-0143-04) * .4 mL in 1 POUCH	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

4312 First Aid Kit

Kit
Honeywell Safety Products USA, INC
NDC: 0498-4312

Purpose:

Sting relief purpose antiseptic topical pain relief

Eyewash purpose eyewash

Alcohol purpose first aid antiseptic

Product Elements:

4312 first aid kit 4312 first aid kit sting relief pad ethyl alcohol, lidocaine benzalkonium chloride menthol water lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol eyesaline emergency eyewash purified water sodium chloride sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water water alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol

Indications and Usage:

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

Alcohol uses first aid to help prevent infection in minor cuts, scrapes, and burns stop use and consult a doctor if condition persists or gets worse

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

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.

Alcohol warnings for external use only flammable, keep away from fire and flame do not use in or near 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 1 week unless directed by a doctor keep out of the 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 1 week 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.

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

Alcohol directions clean the affected area may be covered with a sterile bandage apply wipe to affeted are 1 to 3 times daily discard wipe 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 you experience eye pain changes in vision continued redness or irritation of the eye condition worsens or persists

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

Package Label Principal Display Panel:

Sting relief principal display panel sting relief

Eyewash principal display panel eyesaline

Alcohol principal display panel alcohol preps

4312 kit label sf00004471 4312 label

Further Questions:

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

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

Alcohol 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.