4236 First Aid Kit
Honeywell Safety Products Usa, Inc.
Human Otc Drug
NDC 0498-42364236 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc.'. National Drug Code (NDC) number for 4236 First Aid Kit is 0498-4236. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4236 First Aid Kit drug includes . The currest status of 4236 First Aid Kit drug is Active.
Drug Information:
| Drug NDC: | 0498-4236 |
| 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: | 4236 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: | 4236 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: | 12 Sep, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | 1011852
|
| 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 |
|---|
| 0498-4236-01 | 1 KIT in 1 KIT (0498-4236-01) * 3.5 mL in 1 PACKET (0498-0202-00) * .3 mL in 1 POUCH (0498-0121-00) | 12 Sep, 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. |
Purpose:
Burn jel purpose external analgesic
Pvp wipe purpose first aid antiseptic
Product Elements:
4236 first aid kit 4236 first aid kit burn jel gel for burns edetate disodium edetic acid propylparaben glycerin tea tree oil diazolidinyl urea trolamine methylparaben octoxynol 9 dipropylene glycol carbomer homopolymer type b (allyl pentaerythritol crosslinked) carbomer homopolymer type c lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine
Indications and Usage:
Burn jel uses temporarily relieves pain due to minor burns
Pvp wipe uses first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings:
Burn jel warnings for external use only 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
Pvp wipe 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
Do Not Use:
Burn jel warnings for external use only 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
Pvp wipe 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
When Using:
When using this product avoid contact with eyes
Dosage and Administration:
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
Pvp wipe 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
Stop Use:
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 condition worsens or persists for more than 72 hours irritation and redness develops
Package Label Principal Display Panel:
Burn jel principal display panel burn jel
Pvp wipe principal display panel pvp wipes
4236 kit label 6824cos 4236 label
Further Questions:
Burn jel questions 1-800-430-5490
Pvp wipe questions 800-430-5490