4380 First Aid Kit

4380 First Aid


Honeywell Safety Products Usa, Inc.
Human Otc Drug
NDC 0498-4380
4380 First Aid Kit also known as 4380 First Aid is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc.'. National Drug Code (NDC) number for 4380 First Aid Kit is 0498-4380. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4380 First Aid Kit drug includes . The currest status of 4380 First Aid Kit drug is Active.

Drug Information:

Drug NDC: 0498-4380
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: 4380 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: 4380 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: 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:204602
1038558
1053173
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
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0498-4380-011 KIT in 1 KIT (0498-4380-01) * .9 g in 1 PACKET (0498-0750-35) * 1.4 mL in 1 PACKET (0498-0501-00) * .0019 L in 1 PACKET * 30 mL in 1 BOTTLE (0498-0100-01)13 Sep, 2018N/ANo
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.

Purpose:

Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic

Bzk wipe purpose first aid antiseptic

Eyewash purpose eyewash

Paws purpose antiseptic

Product Elements:

4380 first aid kit 4380 first aid 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 paws ethyl alcohol trolamine aloe vera leaf water alcohol alcohol

Indications and Usage:

Triple uses first aid to help prevent infection in: minor cuts scrapes burns

Bzk wipe uses antiseptic cleansing of face, hands, and body without soap and water

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

Paws uses for handwashing to decrease bacteria on skin whenever soap and water is not readily available

Warnings:

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.

Bzk wipe 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 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.

Paws warnings for external use only flammable: keep away from fire or flame do not use in the eyes. if this happens, rinse thoroughly with water. stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours keep out of reach of children if swallowed, get medical help or contact a poison control center right away

Do Not Use:

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.

Bzk wipe 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 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.

Paws warnings for external use only flammable: keep away from fire or flame do not use in the eyes. if this happens, rinse thoroughly with water. stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours keep out of reach of children if swallowed, get medical help or contact a poison control center right away

Dosage and Administration:

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

Bzk wipe directions tear open packet and use as a washcloth

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

Paws directions wet hands and wrists thoroughly for 15 seconds and allow to air dry always reseal after use children under 6 years of age should be supervised when using this product

Stop Use:

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 if irritation, redness or other symptoms develop the condition persists or gets worse

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 irritation or redness develop and persists for more than 72 hours

Package Label Principal Display Panel:

Triple antibiotic label triple

Antiseptic towelette label baz label

Eyewash eye wash label

Paws label paws label

4380 kit label sf00003593 4380 kit label

Further Questions:

Triple questions? 1-800-430-5490

Bzk wipe questions 1-800-430-5490

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

Paws 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.