4334 First Aid Kit


Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-4334
4334 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4334 First Aid Kit is 0498-4334. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4334 First Aid Kit drug includes . The currest status of 4334 First Aid Kit drug is Active.

Drug Information:

Drug NDC: 0498-4334
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: 4334 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: 4334 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: 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:198440
199005
204602
213034
797544
1011852
1038558
1190560
2056934
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
0041388003023
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
0498-4334-011 KIT in 1 KIT (0498-4334-01) * 1.4 mL in 1 PACKET (0498-0501-00) * 2 TABLET in 1 PACKET (0498-2110-01) * .3 mL in 1 POUCH (0498-0121-00) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0750-35) * 3.5 g in 1 PACKET (0498-0203-00) * 14 g in 1 TUBE * .4 mL in 1 POUCH (0498-0143-04)18 Oct, 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

Alcohol purpose first aid antiseptic

Foille purpose external analgesic antiseptic

Burn jel purpose external analgesic

Sting relief purpose antiseptic topical pain relief

Pvp purpose first aid antiseptic

Aypanal ex purpose pain reliever/fever reducer

Bzk purpose first aid antiseptic

Product Elements:

4379 first aid kit 4379 first aid kit alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol blistex foille medicated first aid benzocaine and chloroxylenol ceresin eugenol maleic anhydride polyethylene glycol 1500 corn oil sodium borate yellow wax calcium hydroxide water chloroxylenol chloroxylenol benzocaine benzocaine sodium lauryl sulfate benzyl alcohol edetate calcium disodium anhydrous calcium cation burn jel gel for burns trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) propylparaben octoxynol-9 tea tree oil diazolidinyl urea edetate disodium edetic acid dipropylene glycol glycerin methylparaben lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium sting relief pad ethyl alcohol, lidocaine menthol water benzalkonium chloride lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine aypanal ex acetaminophen stearic acid sodium starch glycolate type a potato microcrystalline cellulose starch, corn povidone acetaminophen acetaminophen fr1 triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin 4334 first aid kit 4334 first aid kit antiseptic towelette benzalkonium chloride water benzalkonium chloride benzalkonium sting relief pad ethyl alcohol, lidocaine menthol water benzalkonium chloride lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol alcohol pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine aypanal ex acetaminophen stearic acid sodium starch glycolate type a potato microcrystalline cellulose starch, corn povidone acetaminophen acetaminophen fr1 triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum polymyxin b sulfate polymyxin b bacitracin zinc bacitracin neomycin sulfate neomycin alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol blistex foille medicated first aid benzocaine and chloroxylenol sodium lauryl sulfate benzyl alcohol edetate calcium disodium anhydrous calcium cation ceresin eugenol maleic anhydride polyethylene glycol 1500 corn oil sodium borate yellow wax calcium hydroxide water chloroxylenol chloroxylenol benzocaine benzocaine burn jel gel for burns trolamine carbomer homopolymer type c (allyl pentaerythritol crosslinked) carbomer homopolymer type b (allyl pentaerythritol crosslinked) propylparaben octoxynol-9 tea tree oil diazolidinyl urea edetate disodium edetic acid dipropylene glycol glycerin methylparaben lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous

Indications and Usage:

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

Alcohol uses first aid to help prevent infection in minor cuts, scrapes, and burns

Foille uses for the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. first aid to help prevent infection in minor cuts, scrapes and burns.

Burn jel uses temporarily relieves pain due to minor burns

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

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

Aypanal ex uses temporarily relieves minor aches and pains due to the common cold and headache temporarily reduces fever

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

Warnings:

Triple warnings for external use only allergy alert 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.

Alcohol warnings for external use only flammable, keep away from fire or flame. 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 when using this product do not use longer than one week unless directed by a doctor stop use and consult a doctor if condition persists or gets worse keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Foille warnings for external use only when using this product avoid contact with the eyes stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Burn jel warnings for external use oonly do not use on large areas of the body, particularly over raw surfaces or blistered areas when using this product avoid contact with eyes stop use and ask a doctor if the condition gets worse symptoms persist for more than 7 days condition clears up and recurs within a few days keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

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.

Pvp 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.

Aypanal ex warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if skin reaction occurs, stop use and seek medical help right away do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present keep out of reach of children. overdose wa
rning: in case ofl overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. if pregnant or breastfeeding, ask a health professional before use.

Bzk 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.

Do Not Use:

Triple warnings for external use only allergy alert 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.

Alcohol warnings for external use only flammable, keep away from fire or flame. 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 when using this product do not use longer than one week unless directed by a doctor stop use and consult a doctor if condition persists or gets worse keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Foille warnings for external use only when using this product avoid contact with the eyes stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Burn jel warnings for external use oonly do not use on large areas of the body, particularly over raw surfaces or blistered areas when using this product avoid contact with eyes stop use and ask a doctor if the condition gets worse symptoms persist for more than 7 days condition clears up and recurs within a few days keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

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.

Pvp 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.

Aypanal ex warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if skin reaction occurs, stop use and seek medical help right away do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present keep out of reach of children. overdose warning: in case ofl overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. if pregnant or breastfeeding, ask a health professional before use.

Bzk 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.

When Using:

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

When using this product avoid contact with the eyes

When using this product avoid contact with eyes

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

Alcohol directions clean the affected area apply wipe to affected area 1 to 3 times daily may be covered with a sterile bandage discard wipe after single use

Foille directions clean the affected area. adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: consult a physician.

Burn jel directions adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor you may report a serious reaction to this product to 800-430-5490

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.

Pvp 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

Aypanal ex directions do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 tablets with water every 6 hours while symptoms last. do not take any more than 8 tablets in 24 hours. children under 12: consult a doctor

Bzk directions tear open packet and use as a washcloth

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 consult a doctor if condition persists or gets worse

Stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition gets worse symptoms persist for more than 7 days condition clears up and recurs within a few days

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 condition worsens or persists for more than 72 hours irritation and redness develops

Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present

Stop use and ask a doctor if if irritation, redness or other symptoms develop the condition persists or gets worse

Package Label Principal Display Panel:

Triple principal display panel triple antibiotic

Alcohol principal display panel alcohol preps

Foille principal display panel foille

Burn jel principal display panel burn jel

Sting relief principal display panel sting relief

Pvp principal display panel pvp wipe

Aypanal ex principal display panel aypanal ex

Bzk principal display panel antiseptic towelette

4334 kit label z019819 4334 label

4373 kit label z63158002 4379 label

Further Questions:

Burn jel questions 1-800-430-5490

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

Pvp questions 800-430-5490

Aypanal ex questions or comments? 1-800-430-5490

Bzk 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.