NDC 64709-178 Travel Lite Hand Sanitizing Gel

Travel Lite Hand Sanitizing Gel

NDC Product Code 64709-178

NDC CODE: 64709-178

Proprietary Name: Travel Lite Hand Sanitizing Gel 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: Travel Lite Hand Sanitizing Gel 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

  • 64709 - Diamond Wipes International, Inc

NDC 64709-178-20

Package Description: 1 mL in 1 PACKET

NDC Product Information

Travel Lite Hand Sanitizing Gel with NDC 64709-178 is a a human over the counter drug product labeled by Diamond Wipes International, Inc. The generic name of Travel Lite Hand Sanitizing Gel is travel lite hand sanitizing gel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Diamond Wipes International, Inc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Travel Lite Hand Sanitizing Gel 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 70 mL/100mL

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.

  • OAT (UNII: Z6J799EAJK)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CUCUMBER (UNII: YY7C30VXJT)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

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: Diamond Wipes International, Inc
Labeler Code: 64709
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: 10-30-2020 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.

Travel Lite Hand Sanitizing Gel Product Label Images

Travel Lite Hand Sanitizing Gel 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(S)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• for hand sanitizing to decrease bacteria on skin• recommended for repeated use

Warnings

  • For external use onlyFlammable, Keep away from heat or flame

When Using This Product

• avoid contact with eyes. if in eyes, flush with water• do not ingest

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 immediately

Directions

• place small amount in your palm and rub hands together until dry• children under 6 years of age should be supervised when using this product

Other Information

• do not store above 110F (43C)• store in an area inaccessible to children

Inactive Ingredients

Water, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Althaea Officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

Label

DO NOT DRINK(NOT FOR CONSSUMPTION)Help prevent the spread of harmful germsMoisturizing formula keeps hands softGreat for travel, purses, backpacks and anywhere on the go©2020 Diamond Wipes International, Inc. All rights reserved.Chino, CA91710 Wipes123.com800-454-1077UPC 766670071428travel lite TMMAKE IN U.S.A. with global componentsHAND SANITIZING WIPESkills 99.9% of germsAlcohol-basedMoisturizing formula with aloeand botanical extractsVegan • Cruelty-Free • Gluten-FreeParaben-Free • Non-Gmo •Sulfate-Free • Phthalate-Free •Triclosan-FreeNet Wt. 1 Fl OZ / 30mL

* Please review the disclaimer below.