NDC 65585-380 Pacific Breeze Instant Hand Sanitizer Gel
Alcohol Gel Topical

Product Information

What is NDC 65585-380?

The NDC code 65585-380 is assigned by the FDA to the product Pacific Breeze Instant Hand Sanitizer Gel which is a human over the counter drug product labeled by Whisk Products, Inc.. The generic name of Pacific Breeze Instant Hand Sanitizer Gel is alcohol. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 65585-380-01 6 bag in 1 box / 1 l in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code65585-380
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.		Pacific Breeze Instant Hand Sanitizer Gel
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
Substance Name What is the Substance Name?
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.		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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Whisk Products, Inc.
Labeler Code65585
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.		part333E
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.		03-03-2023
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.		12-31-2024
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

What are the uses for Pacific Breeze Instant Hand Sanitizer Gel?


Product Characteristics

Color(s)WHITE (C48325 - WATER WHITE - COLORLESS, CRYSTAL CLEAR)

Product Packages

NDC Code 65585-380-01

Package Description: 6 BAG in 1 BOX / 1 L in 1 BAG

Product Details

What are Pacific Breeze Instant Hand Sanitizer Gel Active Ingredients?

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.

Pacific Breeze Instant Hand Sanitizer Gel Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Pacific Breeze Instant Hand Sanitizer Gel Inactive Ingredients UNII Codes

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.

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Pacific Breeze Instant Hand Sanitizer Gel Product Label

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.

Product Label Table of Contents



Active Ingredient



Ethyl Alcohol 60% v/v


Purpose



Skin Sanitizer


Use



To help reduce the amount of bacteria on skin


Warnings



Flammable.  Keep away from fire or flame.

For external use only.  If swallowed, seek medical attention.

When using this product do not use around or near the eyes.  If contact occurs, flush eyes with water and contact a doctor immediately.

Stop use and consult a doctor when skin irritation appears and lasts.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Directions



  • Place 5 grams or palmful of product in one hand.
  • Spread on hands and run into skin until dry.
  • Place a smaller amount (2.5) grams in one hand and spread over both hands and wrists.
  • Rub into skin until dry.
  • Children should be supervised while using this product.

Inactive Ingredients



Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine


Package Label.Principal Display Panel



Label for 6 x 1000 mL Bags - CaseLabelCF 6 01

Label for 6 x 1000 mL Bags - CaseLabelCF 6 01


* Please review the disclaimer below.