NDC 96285-001 Travelsheld Sanitizing Wipe(70%alcohol)

Travelsheld Sanitizing Wipe

NDC Product Code 96285-001

NDC CODE: 96285-001

Proprietary Name: Travelsheld Sanitizing Wipe(70%alcohol) 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: Travelsheld Sanitizing Wipe 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.

NDC Code Structure

  • 96285 - Yangzhou Zhouwan Medical Devices Co.,ltd
    • 96285-001 - Travelsheld Sanitizing Wipe(70%alcohol)

NDC 96285-001-01

Package Description: 20 PACKET in 1 BOX > 1 PATCH in 1 PACKET > 3.915 mL in 1 PATCH

NDC Product Information

Travelsheld Sanitizing Wipe(70%alcohol) with NDC 96285-001 is a a human over the counter drug product labeled by Yangzhou Zhouwan Medical Devices Co.,ltd. The generic name of Travelsheld Sanitizing Wipe(70%alcohol) is travelsheld sanitizing wipe. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Yangzhou Zhouwan Medical Devices Co.,ltd

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.

Travelsheld Sanitizing Wipe(70%alcohol) 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.

  • ALCOHOL 7 mL/10mL

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.

  • 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.
  • 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: Yangzhou Zhouwan Medical Devices Co.,ltd
Labeler Code: 96285
FDA Application Number: part333E 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: 11-05-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Travelsheld Sanitizing Wipe(70%alcohol) Product Label Images

Travelsheld Sanitizing Wipe(70%alcohol) 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

Otc - Active Ingredient

Ethyl Alcohol 70%

Otc - Purpose

Antimicrobial

Uses

To help reduce microbes on the skin

Directions

Apply to hands or skin.

No rinsing required.Discard after use.

Otc - When Using

Avoid contactwith eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Irritationor redness develops and lasts.

Otc - Keep Out Of Reach Of Children

Ln case ofaccidental ingestion,get medical help orcontact a poison control center immediately.

Inactive Ingredient

Water(Aqua)

Warnings

For external use only

Do not dispose of wipes in flush toilets
Keep away from fire or flame

Other Safety Information

Store below 110°F(43°C)

May discolor certain fabrics or surfaces

* Please review the disclaimer below.