Sanitizing Wipes Alcohol Free Fragrance Free
Benzalkonium Chloride
Goodearth Distribution Llc
Human Otc Drug
NDC 71745-002Sanitizing Wipes Alcohol Free Fragrance Free also known as Benzalkonium Chloride is a human otc drug labeled by 'Goodearth Distribution Llc'. National Drug Code (NDC) number for Sanitizing Wipes Alcohol Free Fragrance Free is 71745-002. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Sanitizing Wipes Alcohol Free Fragrance Free drug includes Benzalkonium Chloride - 1.3 mg/1 . The currest status of Sanitizing Wipes Alcohol Free Fragrance Free drug is Active.
Drug Information:
| Drug NDC: | 71745-002 |
| 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: | Sanitizing Wipes Alcohol Free Fragrance Free |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Sanitizing Wipes |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Alcohol Free Fragrance Free |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Goodearth Distribution Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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 - 1.3 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | CUTANEOUS
|
| 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 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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. |
| Application Number: | part333E |
| 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: | GoodEarth Distribution Llc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1038558
|
| 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 |
|---|
| 71745-002-02 | 2 POUCH in 1 BOX (71745-002-02) / 1800 CLOTH in 1 POUCH (71745-002-01) | 01 Jan, 2022 | 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 antimicrobal
Product Elements:
Sanitizing wipes alcohol free fragrance free benzalkonium chloride water propylene glycol caprylyl/capryl oligoglucoside poly(laurylglucoside)-7 phenoxyethanol benzoic acid dehydroacetic acid benzalkonium chloride benzalkonium
Indications and Usage:
Use hand sanitizer to help reduce bacteria on the skin. recommended for repeated use.
Warnings:
Warnings for external use only. when using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly in water. discontinue use if irritation and redness develop. if conditions persist for more than 72 hours, consult a physician. if swallowed get medical help or contact a poison control center immediately. keep out of reach of children.
When Using:
When using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly in water.
Dosage and Administration:
Directions wet hands thoroughly with product and allow to dry. be sure to use entire wipe. discard after single use. children under 6 years of age should be supervised when using this product.
Stop Use:
Discontinue use if irritation and redness develop. if conditions persist for more than 72 hours, consult a physician.
Package Label Principal Display Panel:
Principal display panel goodearth sanitizing wipes alcohol free fragrance free kills 99.99% of most common germs that may cause illness premium fabric quickly removes dirt and soil contains 1800 sheets 8" x 5" to open package: 1 cut open top of bag and remove plastic tube. 2 locate wipe at center of roll. do not pull wipe from side of roll. 3 insert corner of wipe through opening in dispenser. next sheet pops up automatically. made in canada manufactured for and distributed by: goodearth distribution llc cs@goodearthproducts.com +1-201-363-1900 www.goodearthproducts.com do good. be good. tm goodearth goodearth
Further Questions:
Questions questions? 1-201-363-1900