NDC 64092-307 Skin Protectant


NDC Product Code 64092-307

NDC CODE: 64092-307

Proprietary Name: Skin Protectant 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.

Non-Proprietary Name: Alcohol 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.

Product Characteristics

WHITE (C48325 - CLEAR)

NDC Code Structure

  • 64092 - Great Lakes Wholesale, Marketing, And Sales, Inc

NDC 64092-307-02

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Skin Protectant with NDC 64092-307 is a a human over the counter drug product labeled by Great Lakes Wholesale, Marketing, And Sales, Inc. The generic name of Skin Protectant is alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 247835.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Skin Protectant 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.

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: Great Lakes Wholesale, Marketing, And Sales, Inc
Labeler Code: 64092
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: 06-30-2016 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 - NO 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".

* Please review the disclaimer below.

Skin Protectant Product Label Images

Skin Protectant 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


GLS PERSONAL CARE SOLUTIONSINSTANT HAND SANITIZERwith carabinerWith Moisturizers and Vitamin EElimates 99.9% of germs2 pack 2 FL. OZ. (60mL) [4 FL OZ (120 mL) total]

Otc - Active Ingredient

Active Ingredient PurposeEthyl Alcohol..........................................................................Antiseptic

Otc - Purpose

Decrease bacteria on the skin.

Indications & Usage

For handwashing when water, soap and towels are not available.Recommended for repeated use.Clips securely on purses, backpacks and shoulder bags.Provides portable defense against illness, germs and infection.


For external use OnlyFlammable. Keep away from heat and flame.Do not store above 40°C(105°F)Do not use in mouth, ears or eyes.When using this product, avoid contact with eyes.In case of contact, flush eyes with water.Stop use and seek a doctor if redness or irritation develops and persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Chidren must be supervised in use of this product.

Instructions For Use

Pump as needed into your palms and thoroughly spread on both hands.Rub into skin until dry.

Dosage & Administration

Hand wash when water, soap and towel are not availabe.62% Ethyl Alcohol.

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F)May discolor fabrics.

Inactive Ingredient

Deionized water, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, amonimethyl propanol, carbomer and fragrance.

* Please review the disclaimer below.