NDC 57915-009 Germstargel

Ethyl Alcohol

NDC Product Code 57915-009

NDC 57915-009-01

Package Description: 236 g in 1 BOTTLE, PUMP

NDC Product Information

Germstargel with NDC 57915-009 is a a human over the counter drug product labeled by Soaptronic, Llc. The generic name of Germstargel is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Soaptronic, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Germstargel 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 630 g/1000g

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Soaptronic, Llc
Labeler Code: 57915
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: 01-01-2021 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.

Germstargel 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

Active
ingredient              


Ethyl alcohol 63% (W/W)

Otc - Purpose

PurposeAntiseptic

Indications & Usage

UsesKills 99.99% of all disease causing germs on contact, and protects and restores moisture.

Warnings

WarningsFor
external use only. Keep out of eyes. In case of eye contact immediately
flush eyes with water. If irritation persists, get medical attention.
If swallowed, contact physician. Flammable, keep away from heat or
flames. Germstar Wipes are safe for most surfaces, however can be
harmful to some. Test wipe on a non-conspicuous area if unsure.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

DirectionsApply Germstar all over the surface of your hands and rub into skin until dry. Supervise children in the use of this product.

Other

Other informationGermstar is non allergenic. Store at 20° to 25°C (68° to 77°F). May be harmful to some surfaces/materials.

Inactive Ingredient

Inactive ingredientsWater, Isopropanol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Fragrance

Otc - Questions

Questions?Call Germstar at 1-800.327.2606

Germstargel

Germstar Gel

* Please review the disclaimer below.