NDC 77807-004 Aurora Fresh Gel 70
Alcohol Gel Topical

Product Information

Product Code77807-004
Proprietary Name 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.
Aurora Fresh Gel 70
Non-Proprietary Name 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.
Alcohol
Product Type 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.
Human Otc Drug
Dosage FormGel - 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.
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.
  • 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.
Aurora Specialty Chemistries
Labeler Code77807
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-23-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 77807-004-04

Package Description: 3.785 L in 1 BOTTLE

NDC 77807-004-08

Package Description: 3.785 L in 1 BOTTLE, PUMP

NDC 77807-004-09

Package Description: .05 L in 1 BOTTLE, DISPENSING

NDC 77807-004-10

Package Description: .473 L in 1 BOTTLE, PUMP

Product Details

Aurora Fresh Gel 70 is a human over the counter drug product labeled by Aurora Specialty Chemistries. The generic name of Aurora Fresh Gel 70 is alcohol. The product's dosage form is gel and is administered via topical form.


What are Aurora Fresh Gel 70 Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • CITRAL (UNII: T7EU0O9VPP)


* Please review the disclaimer below.

Aurora Fresh Gel 70 Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



This is a gel hand sanitizer with citrus fragrance manufactured according to standard CGMP.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with existing hand sanitizer products sold OTC throughout the United States and Globally:

Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (1.39% v/v).
Hydroxymethyl Cellulose (0.7% v/v).
Isopropyl Myristate (0.07% v/v)
DL-Alpha-Tocopherol Acetate (0.07% v/v)
Citral (0.07% v/v)
Sterile distilled water (27.7% v/v).

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.


Active Ingredient(S)



Isopropyl Alcohol 70% 


Purpose



Antiseptic / Hand Sanitizer


Use(S)



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


Warnings



For external use only. Flammable. Keep away from flame.


Do Not Use



  • In children less than 2 months of age
  • On open skin wounds

Otc - When Using



When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may besigns of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Otc - Stop Use



Stop use and ask a doctor if irritation or rash occurs. These may besigns of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.


Other Information



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


Inactive Ingredients



deionized water, glycerin, hydroxypropyl cellulose, tocopheryl acetate, isopropyl myristate, fragrance


Package Label - Principal Display Panel



1 Gallon (3.785 L) NDC: 77807-004-08


* Please review the disclaimer below.