NDC 79930-7106 Acqua Di Gabrial

Hand Sanitizing Mist Herbal

NDC Product Code 79930-7106

NDC 79930-7106-1

Package Description: 125 mL in 1 BOTTLE, SPRAY

NDC 79930-7106-4

Package Description: 500 mL in 1 BOTTLE, SPRAY

NDC Product Information

Acqua Di Gabrial with NDC 79930-7106 is a a human over the counter drug product labeled by Nexderma. The generic name of Acqua Di Gabrial is hand sanitizing mist herbal. The product's dosage form is spray and is administered via topical form.

Labeler Name: Nexderma

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.

Acqua Di Gabrial 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 75 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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • SILVER (UNII: 3M4G523W1G)
  • WATER (UNII: 059QF0KO0R)
  • ALLANTOIN (UNII: 344S277G0Z)
  • SILVER (UNII: 3M4G523W1G)
  • 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: Nexderma
Labeler Code: 79930
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: 09-30-2020 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.

Acqua Di Gabrial 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)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Allantoin

Ultra Pure Water

Silver

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Otc - Keep Out Of Reach Of Children

Adult supervision recommended for children under 6 years old.

Warnings

Keep away form fire and flame.

Flammable

For external use on hands only.

Keep out of eye, ears and mouth.

If contact in eyes, flush thoroughly with water.

Keep out of reach of children.

If swallowed seek medical help immediately or call your poison control center.

Store between 15-30 (58-86F)

Avoid freezing and excessive heat above 40C (104F)

Will damage wood finishes, plastics and some fabrics.

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Directions

  • Dosage: Place enough product on hands to cover all surfaces. Rub hands together until dry.Administration:Topoical

Purpose

Purpose: to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

* Please review the disclaimer below.