NDC 79416-556 Travel Assure Advanced Hand Sanitizer

Isopropyl Alcohol

NDC Product Code 79416-556

NDC 79416-556-01

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC Product Information

Travel Assure Advanced Hand Sanitizer with NDC 79416-556 is a a human over the counter drug product labeled by Dermapeutics. The generic name of Travel Assure Advanced Hand Sanitizer is isopropyl alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Dermapeutics

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 Assure Advanced Hand Sanitizer 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.

  • ISOPROPYL 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • ORANGE OIL (UNII: AKN3KSD11B)

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: Dermapeutics
Labeler Code: 79416
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: 07-07-2020 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 Assure Advanced Hand Sanitizer Product Label Images

Travel Assure Advanced Hand Sanitizer 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

Isopropyl Alcohol 70%

Purpose

Antimicrobial

Use

  • For hand washing to decrease bacteria on the skinRecommended for repeated use

Warnings

  • Do not use in the eyes. In case of contact rinse thoroughly with waterDo not use on children less than 2 months of age.For external use only.Flammable, keep away from heat and flame.Stop use and ask doctor if Irritation and redness develop and persist for more than 72hrsSwallowed, get medical attention or contact poison control center right away.

Directions:

  • Spray product into palm to cover hands and rub hands together until dry.Children under 6 years of age should be supervised when using this product.

Other Information:

  • Store below 110°F (43°C)May discolor certain fabrics or surfaces

* Please review the disclaimer below.