4065 First Aid Kit
Honeywell Safety Products Usa, Inc
Human Otc Drug
NDC 0498-40654065 First Aid Kit is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc'. National Drug Code (NDC) number for 4065 First Aid Kit is 0498-4065. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4065 First Aid Kit drug includes . The currest status of 4065 First Aid Kit drug is Active.
Drug Information:
| Drug NDC: | 0498-4065 |
| 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: | 4065 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: | 4065 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: | 21 Nov, 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: | 204602
1012100
|
| 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 |
|---|
| 0498-4065-01 | 1 KIT in 1 KIT (0498-4065-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0750-35) * 10 POUCH in 1 CARTON (0498-0121-34) / .3 mL in 1 POUCH (0498-0121-00) | 21 Nov, 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:
Pvp wipes purpose first aid antiseptic
Burn cream purpose first aid antiseptic external analgesic
Triple purpose first aid antibiotic first aid antibiotic first aid antibiotic
Product Elements:
4064 first aid kit 4064 first aid kit pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine first aid burn benzalkonium chloride, lidocaine hydrochloride glycerin glyceryl monostearate propylparaben propylene glycol aloe vera leaf diazolidinyl urea stearic acid methylparaben peg-100 stearate cetyl alcohol trolamine water edetate disodium edetic acid light mineral oil lidocaine hydrochloride lidocaine lidocaine hydrochloride benzalkonium chloride benzalkonium triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum bacitracin zinc bacitracin polymyxin b sulfate polymyxin b neomycin sulfate neomycin 4065 first aid kit 4065 first aid kit pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine first aid burn benzalkonium chloride, lidocaine hydrochloride glycerin glyceryl monostearate propylparaben propylene glycol aloe vera leaf diazolidinyl urea stearic acid methylparaben peg-100 stearate cetyl alcohol trolamine water edetate disodium edetic acid light mineral oil lidocaine hydrochloride lidocaine lidocaine hydrochloride benzalkonium chloride benzalkonium triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum bacitracin zinc bacitracin polymyxin b sulfate polymyxin b neomycin sulfate neomycin 4066 first aid kit 4066 first aid kit pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine first aid burn benzalkonium chloride, lidocaine hydrochloride lidocaine hydrochloride lidocaine lidocaine hydrochloride benzalkonium chloride benzalkonium glycerin glyceryl monostearate propylparaben propylene glycol aloe vera leaf diazolidinyl urea stearic acid methylparaben peg-100 stearate cetyl alcohol trolamine water edetate disodium edetic acid light mineral oil triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum bacitracin zinc bacitracin polymyxin b sulfate polymyxin b neomycin sulfate neomycin 4067 first aid kit 4067 first aid kit pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine first aid burn benzalkonium chloride, lidocaine hydrochloride glycerin glyceryl monostearate propylparaben propylene glycol aloe vera leaf diazolidinyl urea stearic acid methylparaben peg-100 stearate cetyl alcohol trolamine water edetate disodium edetic acid light mineral oil lidocaine hydrochloride lidocaine lidocaine hydrochloride benzalkonium chloride benzalkonium triple antibiotic bacitracin zinc, polymyxin b sulfate, neomycin sulfate petrolatum bacitracin zinc bacitracin polymyxin b sulfate polymyxin b neomycin sulfate neomycin
Indications and Usage:
Pvp wipes uses first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Burn cream uses prevent skin infection for temporary relief of pain associated with miinor burns
Triple uses first aid to help prevent infection in: minor cuts scrapes burns
Warnings:
Pvp wipes 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.
Burn cream warnings for external use only do not use in or near the eyes if you are allergic to any of the ingredients in large areas of the body particularly over raw surfaces or blistered areas for more than 10 days ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition persists symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of chidren if swallowed, get medical help or contact a poison control center right away.
Triple warnings for external use only allergy alert: do not use if you are allergic to any of the ingredients triple do not use in the eyes over large areas of the body triple ask a doctor before use if you have deep or puncture wounds animal bites serious burns triple 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 triple keep out of reach of children if swallowed, get medical help or contact a poison control center right away
Do Not Use:
Pvp wipes 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.
Burn cream warnings for external use only do not use in or near the eyes if you are allergic to any of the ingredients in large areas of the body particularly over raw surfaces or blistered areas for more than 10 days ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition persists symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of chidren if swallowed, get medical help or contact a poison control center right away.
Triple warnings for external use only allergy alert: do not use if you are allergic to any of the ingredients triple do not use in the eyes over large areas of the body triple ask a doctor before use if you have deep or puncture wounds animal bites serious burns triple 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 triple keep out of reach of children if swallowed, get medical help or contact a poison control center right away
Dosage and Administration:
Pvp wipes 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
Burn cream directions adults and children 2 years of age and older: clean the affected area apply a small amount of this product (equal to the area of the tip of finger) onto the affected area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor
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
Stop Use:
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 condition persists symptoms persist for more than 7 days or clear up and occur again within a few days
Triple 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
Package Label Principal Display Panel:
Honeywell pvp wipes honeywell pvp wipe
Burn cream principal display panel burn cream
Triple principal display panel triple antibiotic
4064 kit label z019737-0024l 4064 kit
4065 kit label 019737-0024l 4065 kit
4066 kit label z019839 4066 kit
4067 kit label 019708-0005l 4067 kit
Further Questions:
Pvp wipes questions 800-430-5490
Burn cream questions 1-800-430-5490
Triple questions 1-800-430-5490