Dermacinrx Surgical Combopak
Chlorhexidine Gluconate Surgical Combo Kit
Puretek Corporation
Human Prescription Drug
NDC 59088-334Dermacinrx Surgical Combopak also known as Chlorhexidine Gluconate Surgical Combo Kit is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Dermacinrx Surgical Combopak is 59088-334. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Dermacinrx Surgical Combopak drug includes . The currest status of Dermacinrx Surgical Combopak drug is Active.
Drug Information:
| Drug NDC: | 59088-334 |
| 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: | Dermacinrx Surgical Combopak |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Chlorhexidine Gluconate Surgical Combo Kit |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Puretek Corporation |
| 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: | 28 Apr, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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, 2024 |
| 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: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 211365
259090
|
| 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: | 0731477391932
|
| 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 |
|---|
| 59088-334-00 | 1 KIT in 1 PACKAGE (59088-334-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) | 28 Apr, 2015 | 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:
Purpose antiseptic
Product Elements:
Dermacinrx surgical combopak chlorhexidine gluconate surgical combo kit antiseptic skin cleanser chlorhexidine gluconate coco diethanolamide hydroxyethyl cellulose (2000 cps at 1%) isopropyl alcohol lauramine oxide water tridecyl alcohol gluconolactone peg-75 lanolin chlorhexidine gluconate chlorhexidine skin repair complex dimethicone kukui nut oil aloe vera leaf butylene glycol caprylyl glycol safflower oil cetyl alcohol chlorphenesin dimethicone/diene dimethicone crosspolymer edetate disodium glycerin glyceryl monostearate levomenol calcium pantothenate carthamus tinctorius seed oleosomes maltodextrin niacinamide pyridoxine hydrochloride silicon dioxide sodium ascorbyl phosphate .alpha.-tocopherol acetate, dl- ginger peg-100 stearate pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) phenoxyethanol water hyaluronate sodium stearic acid trolamine dimethicone dimethicone
Indications and Usage:
Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing
Uses â for the treatment and/or prevention of diaper rash â temporarily protects and helps relieve chapped or cracked skin
Warnings:
Warnings for external use only do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or
Read more... contact a poison control center right away.
Warnings for external use only do not use on â deep or puncture wounds â animal bites â serious burns when using this product â do not get into eyes stop use and ask a doctor if â condition worsens â symptoms last 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.
Dosage and Administration:
Directions use with care in premature infants and infants under 2 months of age. these products may cause irritation or chemical burns. surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to
Read more...cover the skin or wound area and wash gently rinse again thoroughly
Directions â apply cream liberally as needed
Package Label Principal Display Panel:
Image description