Revitaderm Wound Care
Benzalkonium Chloride
Blaine Labs Inc.
Human Otc Drug
NDC 63347-120Revitaderm Wound Care also known as Benzalkonium Chloride is a human otc drug labeled by 'Blaine Labs Inc.'. National Drug Code (NDC) number for Revitaderm Wound Care is 63347-120. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Revitaderm Wound Care drug includes Benzalkonium Chloride - 170 mg/89mL . The currest status of Revitaderm Wound Care drug is Active.
Drug Information:
| Drug NDC: | 63347-120 |
| 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: | Revitaderm Wound Care |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Blaine Labs Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | BENZALKONIUM CHLORIDE - 170 mg/89mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 24 May, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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. |
| Application Number: | part333A |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Blaine Labs Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049228
1310820
|
| 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: | F5UM2KM3W7
|
| 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 |
|---|
| 63347-120-01 | 89 mL in 1 TUBE (63347-120-01) | 24 May, 2012 | 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 purpose antimicrobial
Product Elements:
Revitaderm wound care benzalkonium chloride benzalkonium chloride benzalkonium aloe vera leaf carbomer interpolymer type a (allyl sucrose crosslinked) hydrolyzed elastin, bovine, alkaline (1000 mw) glycerin hyaluronic acid trolamine phenoxyethanol methylparaben ethylparaben propylparaben butylparaben isobutylparaben
Indications and Usage:
Uses uses * 1st and 2nd degree burns * stasis ulcers * pressure ulcers * diabetic ulcers * lacerations * abrasions * skin tears * surgical incision sites * device insertion sites * graft sites * donor sites
Warnings:
Warnings warnings for external use only.
Dosage and Administration:
Directions directions evenly apply revitaderm wound care approximately 1/8 inch to 1/4 inch thick to the wound area. cover wound with appropriate dressing. repeat as necessary to keep the wound moist.
Package Label Principal Display Panel:
Product label blaine labs revitaderm wound care gel 3 fl. oz. physician formula ndc: 63347-120-01 (800) 307-8818 info@blainelabs.com www.blainelabs.com blaine labs, inc. santa fe springs, ca 90670 rev. 20120820 res blaine revitaderm1 blaine revitaderm2