NDC 64092-369 Skin Protectant Lavender


NDC Product Code 64092-369

NDC CODE: 64092-369

Proprietary Name: Skin Protectant Lavender 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)
PURPLE (C48327)

NDC Code Structure

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

NDC 64092-369-08

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC Product Information

Skin Protectant Lavender with NDC 64092-369 is a a human over the counter drug product labeled by Great Lakes Wholesale, Marketing, And Sales, Inc.. The generic name of Skin Protectant Lavender 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 Lavender 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)
  • 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: 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: 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 Lavender Product Label Images

Skin Protectant Lavender 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 SanitizerEliminates 99.9% of germsKills Germs Without Waterwith Moisturizers & Vitamin E8 fl. oz (237mL)Original, Aloe Vera, Lavender, Sweet Pea

Otc - Active Ingredient

Active Ingredient PurposeEthyl alcohol 62%.................................................Antimicrobial

Otc - Purpose

Kill germs without water

Indications & Usage

To help reduce bacteria on the skin


Flammable. Keep away from fire or flame.For external use onlyWhen using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.Stop use and ask a doctor if irritation or rash appears and lasts.

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison control Center right away.

Instructions For Use

  • Place enough product in your palm to thoroughly cover your handsRub hands together briskly until dryChildren under 6 years of age should be supervised when using this product. .

Dosage & Administration

Instant Hand Sanitizer62% Ethyl alcohol

Storage And Handling

  • Store below 110°F(43°C)May discolor certain fabrics or surfaces.

Inactive Ingredient

Water (aqua), aloe barbadensis leaf juice, carbomer, fragrance, glyerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine.

* Please review the disclaimer below.