NDC 11344-100 Hand Sanitizing Wipes
Ethyl Alcohol Cloth Topical
NDC Product Code 11344-100
Proprietary Name: Hand Sanitizing Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Ethyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used as antiseptic
NDC Code Structure
- 11344 - Vi-jon, Llc
- 11344-100 - Hand Sanitizing Wipes
NDC 11344-100-93
Package Description: 100 PACKET in 1 BOX > 3 mL in 1 PACKET
NDC Product Information
Hand Sanitizing Wipes with NDC 11344-100 is a human over the counter drug product labeled by Vi-jon, Llc. The generic name of Hand Sanitizing Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.
Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Hand Sanitizing Wipes Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
RxNorm Crosswalk
What is RxNorm?RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.
The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- TOCOPHEROL (UNII: R0ZB2556P8)
- WATER (UNII: 059QF0KO0R)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Vi-jon, Llc
Labeler Code: 11344
FDA Application Number: part333A What is the FDA Application Number?
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.
Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
Start Marketing Date: 01-24-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2023 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
* Please review the disclaimer below.
Hand Sanitizing Wipes Product Label Images
Hand Sanitizing Wipes Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- Active Ingredient
- Purpose
- Use
- Warnings
- When Using This Product
- Stop Use And Ask A Doctor If
- Keep Out Of Reach Of Children.
- Directions
- Inactive Ingredients
- Questions?
- Other
Active Ingredient
Ethyl Alcohol 67% v/v
Purpose
Antiseptic
Use
To decrease bacteria on the skin
Warnings
For external use only-handsFlammable. Keep away from fire or flame.
When Using This Product
- Keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingest
Stop Use And Ask A Doctor If
- Irritation and redness developcondition persists for more than 72 hours
Keep Out Of Reach Of Children.
In case of accidental ingestion, see professional assistance or contact a Poison Control Center immediately.
Directions
- Wipe hands thoroughly with product and allow to dryfor children under 6, use only under adult supervisonnot recommended for infants
Inactive Ingredients
Water, tocopheryl acetate, aloe barbadensis leaf juice
Questions?
1-866 MY GERMX - 1-866-694-3769
Other
*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 secondsMade in the USA with US and foreign componentsDistributed byVi-Jon, Inc.8515 Page Ave.St. Louis MO 63114100.000/100AA
* Please review the disclaimer below.