Instant Hand Sanitizer Wipes
Alcohol Hand Sanitizer Wipes
Diamond Wipes International, Inc.
Human Otc Drug
NDC 64709-185Instant Hand Sanitizer Wipes also known as Alcohol Hand Sanitizer Wipes is a human otc drug labeled by 'Diamond Wipes International, Inc.'. National Drug Code (NDC) number for Instant Hand Sanitizer Wipes is 64709-185. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Instant Hand Sanitizer Wipes drug includes Alcohol - 70 mL/100mL . The currest status of Instant Hand Sanitizer Wipes drug is Active.
Drug Information:
| Drug NDC: | 64709-185 |
| 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: | Instant Hand Sanitizer Wipes |
| 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: | Alcohol Hand Sanitizer Wipes |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Diamond Wipes International, Inc. |
| 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: | ALCOHOL - 70 mL/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: | 01 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | 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: | Diamond Wipes International, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1489307
|
| 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: | 3K9958V90M
|
| 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 |
|---|
| 64709-185-10 | 1 mL in 1 PACKET (64709-185-10) | 14 Jul, 2022 | N/A | No |
| 64709-185-11 | 1 mL in 1 BOX (64709-185-11) | 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 antiseptic
Product Elements:
Instant hand sanitizer wipes alcohol hand sanitizer wipes water aloe vera leaf alcohol alcohol .alpha.-tocopherol acetate wipe
Indications and Usage:
Uses for hand sanitizing to decrease bacteria on skin
Warnings:
Warnings for external use only flammable, keep away from fire or flame when using this product contact with eyes. if in eyes, flush thoroughly with water discontinue use and contact a doctor if irritation and redness develop and conditions persists for more than 72 hours
Dosage and Administration:
Directions tear open packet, remove wipe wet hands thoroughly with product and let hands air dry throw used wipe in trash, do not flush
Package Label Principal Display Panel:
Label diamond wipes 99.9% effective against most common germs 1 wipe| instant hand sanitizer wipes aloe vera & vitamin e made in u.s.a. cleans & sanitizes drug facts active ingredient purpose ethyl alcohol 70% v/v antiseptic uses for hand sanitizing to decrease bacteria on skin warnings for external use only flammable: keep away from fire or flame when using this product avoid contact with eyes. if in eyes, flush thoroughly with water discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours keep out of reach of children unless under adult supervision. if swallowed, get medical help or contact a poison control center right away directions tear open packet, remove wipe wet hands thoroughly with product and let hands air dry throw used wipe in trash, do not flush inactive ingredients aloe barbadensis leaf juice, tocopheryl acetate, water escherichia coli, staphylococcus aureus, salmonella typhimurium, pseudomonas aeruginosa, burkholderia cepacia, enterobacter cloacae, enterococcus faecalis, streptococcus pyogenes, candida albicans, aspergillus brasiliensis diamond wipes int"l, inc., chino, ca 91710 1-800-454-1077 www.wipes123.com instant hand sanitizer wipes 99.9% effective against most common germs* diamond wipes instant hand sanitizer wipes kills 99.99% germs made in u.s.a. 100 wipes antimicrobial cleans & sanitizes with vitamin e aloe vera diamond wipes instant hand sanitizer wipes work quickly, effectively, and safely to clean and sanitize skin. antimicrobial 99.9% effective against most common germs* dries in seconds infused with aloe vera and vitamin e, these extra soft wipes gently moisturize and refresh your hands. perfect for: hospitals schools nurseries restaurants cafeterias caterers offices on the go for best results: discard after single use dispose of used wipe in trash do not fush used wipe store at room temperature drug facts active ingredient (in each wipe) purpose 70.0% v/v, ethyl alcohol antiseptic uses for hand sanitizing to decrease bacteria on skin recommended for repeated use warnings for external use only flammable, keep away from fire or flame when using this product avoid contact with eyes. if in eyes, flush thoroughly with water discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours keep out of reach of children. if swallowed, get medical help or contact a poison control center right away directions open packet remove and unfold wipe wet hands thoroughly with product and let hands air dry throw used wipe in trash, do not flush inactive ingredients aloe barbadensis leaf juice, tocopheryl acetate, water made in u.s.a. manufactured by diamond wipes intl, inc., chino, ca 91710 1 (800) 454-1077 www.wipes123.com 2020 all rights reserved single box label