Ca-rezz - Norisc - Incontinent Wash
Benzethonium Chloride
Fnc Medical Corporation
Human Otc Drug
NDC 60762-113Ca-rezz - Norisc - Incontinent Wash also known as Benzethonium Chloride is a human otc drug labeled by 'Fnc Medical Corporation'. National Drug Code (NDC) number for Ca-rezz - Norisc - Incontinent Wash is 60762-113. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Ca-rezz - Norisc - Incontinent Wash drug includes Benzethonium Chloride - .12 g/100mL . The currest status of Ca-rezz - Norisc - Incontinent Wash drug is Active.
Drug Information:
| Drug NDC: | 60762-113 |
| 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: | Ca-rezz - Norisc - Incontinent Wash |
| 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: | Benzethonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fnc Medical Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | BENZETHONIUM CHLORIDE - .12 g/100mL
|
| 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: | 05 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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. |
| 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: | FNC MEDICAL CORPORATION
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1876355
1876392
|
| 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: | PH41D05744
|
| 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 |
|---|
| 60762-113-08 | 237 mL in 1 BOTTLE, SPRAY (60762-113-08) | 05 Feb, 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:
Purpose antibacterial
Product Elements:
Ca-rezz - norisc - incontinent wash benzethonium chloride water sodium laureth sulfate propylene glycol disodium cocoamphodiacetate polysorbate 80 cetyl acetate acetylated lanolin alcohols aloe vera whole anhydrous citric acid phenoxyethanol ethylhexylglycerin d&c yellow no. 10 benzethonium chloride benzethonium
Indications and Usage:
Uses ca-rezz norsic wash has been formulated as an incontinent wash to quickly emulsify body waste even in the most sensitive perineal areas. ca-rezz norsic wash is ph balanced and enriched with aloe vera, to soothe and help promote healing of fragile, irritated skin. stops odors.
Warnings:
Warnings for external use only. if rash or irritation develop, discontinue use. consult a physician if irritation persists.
Dosage and Administration:
Directions spray ca-rezz norsic wash where urine, feces or emesis has soiled skin pad linens and clothing. remove bulk of feces or emesis. spray additional ca-rezz norsic wash on warm wet cloth. cleanse skin of all remaining residue. pat dry. note: if area needing care is sizeable and fecal or emesis material massive, rinsing is advised. add one capful of ca-rezz norsic wash to the regular laundry to eliminate residual odors.
Package Label Principal Display Panel:
Incontinent wash_8oz_lbl
Further Questions:
Questions or comments? please call 1-800-440-2888