Wet Ones Antibacterial Hand Wipes Fresh Scent
Benzalkonium Chloride
Edgewell Personal Care Brands Llc
Human Otc Drug
NDC 63354-995Wet Ones Antibacterial Hand Wipes Fresh Scent also known as Benzalkonium Chloride is a human otc drug labeled by 'Edgewell Personal Care Brands Llc'. National Drug Code (NDC) number for Wet Ones Antibacterial Hand Wipes Fresh Scent is 63354-995. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Wet Ones Antibacterial Hand Wipes Fresh Scent drug includes Benzalkonium Chloride - .13 1/1 . The currest status of Wet Ones Antibacterial Hand Wipes Fresh Scent drug is Active.
Drug Information:
| Drug NDC: | 63354-995 |
| 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: | Wet Ones Antibacterial Hand Wipes Fresh Scent |
| 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: | Edgewell Personal Care Brands Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Swab |
| 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 - .13 1/1
|
| 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: | 27 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jun, 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: | Edgewell Personal Care Brands LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0123123456452
0076828047039
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 63354-995-15 | 20 SWAB in 1 POUCH (63354-995-15) | 27 Apr, 2020 | N/A | No |
| 63354-995-24 | 24 SWAB in 1 PACKET (63354-995-24) | 27 Apr, 2020 | N/A | No |
| 63354-995-40 | 40 SWAB in 1 CANISTER (63354-995-40) | 27 Apr, 2020 | 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 antimicrobial agent
Product Elements:
Wet ones antibacterial hand wipes fresh scent benzalkonium chloride phenoxyethanol water alcohol benzalkonium chloride benzalkonium anhydrous citric acid aloe vera leaf dihydroxypropyl peg-5 linoleammonium chloride peg-8 dimethicone caprylyl glycol potassium sorbate edetate disodium anhydrous
Indications and Usage:
Use decreases bacteria on skin
Warnings:
Warnings for external use only do not use if you are allergic to any of the ingredients when using this product do not get into eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours keep out of reach of children if swallowed, get medical help or contact a poison control center right away
Do Not Use:
Warnings for external use only do not use if you are allergic to any of the ingredients when using this product do not get into eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours keep out of reach of children if swallowed, get medical help or contact a poison control center right away
When Using:
When using this product do not get into eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions adults and childre 2 years and over ⢠apply to hands ⢠allow skin to dry without wiping children under 2 years ask a doctor before use
Stop Use:
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours
Package Label Principal Display Panel:
Primary display panel wet ones (r) antibacterial hand wipes fresh scent kills 99.99% of germs hypoallergenic paraben free fresh, clean feel america's #1 hand wipe* 40 wipes fresh, clean feel wet ones(r) antibacterial hand wipes fresh scent kills 99.99% of germs hypoallergenic wet lock(tm) seal keeps wipes moist lift here 20 wipes 63354-995-40 63354-995-15 pouch 63354-995-15 label wipe packet