Secura Personal Cleanser
Benzethonium Chloride
Smith & Nephew Medical Ltd
Human Otc Drug
NDC 69740-305Secura Personal Cleanser also known as Benzethonium Chloride is a human otc drug labeled by 'Smith & Nephew Medical Ltd'. National Drug Code (NDC) number for Secura Personal Cleanser is 69740-305. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Secura Personal Cleanser drug includes Benzethonium Chloride - 1.3 mg/mL . The currest status of Secura Personal Cleanser drug is Active.
Drug Information:
| Drug NDC: | 69740-305 |
| 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: | Secura Personal Cleanser |
| 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: | Smith & Nephew Medical Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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 - 1.3 mg/mL
|
| 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: | 01 Aug, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Nov, 2023 |
| 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: | 14 May, 2026 |
| 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: | Smith & Nephew Medical Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 582205
|
| 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 |
|---|
| 69740-305-00 | 3780 mL in 1 BOTTLE, SPRAY (69740-305-00) | 01 Aug, 2003 | 30 Nov, 2023 | 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 antimicrobial
Product Elements:
Secura personal cleanser benzethonium chloride benzethonium chloride benzethonium benzyl alcohol anhydrous citric acid d&c red no. 33 diazolidinyl urea edetate disodium methylparaben octoxynol-9 polysorbate 20 propylene glycol water trisodium citrate dihydrate secura personal cleanser benzethonium chloride benzethonium chloride benzethonium benzyl alcohol anhydrous citric acid d&c red no. 33 diazolidinyl urea edetate disodium methylparaben octoxynol-9 polysorbate 20 propylene glycol trisodium citrate dihydrate water
Indications and Usage:
Uses antimicrobial skin cleanser for the perineum or body aids in the removal of urine, feces, or other foreign material
Warnings:
Warnings for external use only avoid contact with eyes not to be applied over deep puncture wounds, infections, or lacerations if condition worsens or does not improve within 7 days, contact a doctor keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately
Do Not Use:
Warnings for external use only avoid contact with eyes not to be applied over deep puncture wounds, infections, or lacerations if condition worsens or does not improve within 7 days, contact a doctor keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately
When Using:
For external use only avoid contact with eyes
Dosage and Administration:
Directions apply cleanser liberally on affected area, then wipe clean no rinsing necessary
Stop Use:
If condition worsens or does not improve within 7 days, contact a doctor
Package Label Principal Display Panel:
Package label - principal display panel - secura personal cleanser (236ml) #59430400 ndc 69740-304-00 personal cleanser antimicrobial skin cleanser no-rinse, one-step cleansing for perineum or body gently removes urine, feces, and other body fluids reduces odor ph-buffered pediatric tested chg compatible smith&nephew secura â personal cleanser 8 fl oz. (236ml) made in usa for: smith & nephew medical ltd 101 hessle road hull, hu3 2bn england www.smith-nephew.com trademark of smith & nephew. certain marks regâd in u.s. pat. and tm. off package display - personal cleanser (236 ml)
Package label - principal display panel - secura personal cleanser (3.78l) #59430500 ndc 69740-305-00 personal cleanser antimicrobial skin cleanser no-rinse, one-step cleansing for perineum or body gentle surfactants emulsify stool without friction reduces odor ph-buffered pediatrician tested chg compatible smith&nephew secura â personal cleanser 1 gallon (3.78l) made in usa for: smith & nephew medical ltd 101 hessle road hull, hu3 2bn england www.smith-nephew.com trademark of smith & nephew. package display - personal cleanser (236 ml)
Further Questions:
Question or comments? 1 800 876-1261