NDC 64092-209 Skin Protectant


NDC Product Code 64092-209

NDC CODE: 64092-209

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: Petrolatum 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)

NDC Code Structure

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

NDC 64092-209-04

Package Description: 133 mL in 1 TUBE

NDC Product Information

Skin Protectant with NDC 64092-209 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 petrolatum. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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 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 SOLUTIONSCreamy Petroleum JellyNourishing Vitamin Efor Dry SkinSkin ProtectantMoisturizingAbsorbs quicklyMoisturizingHelps restore skin's natural moisture4.5 fl. oz. (133 ml)

Otc - Active Ingredient

White Petroleum PurposePetrolatum 30%.............................................................Skin Protectant

Otc - Purpose

Skin Protectant Lotion for dry Skin

Indications & Usage

Temporarily protect minor cuts, scrapes, & burnsTemporarily protects and helps relieve chapped or cracked skinHelps protect from the drying effects of wind and cold weather


For external use only.When using this product do not get into eyes.Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days.Do not use on - deep puncture wounds - animal bites - serious burns

Otc - Keep Out Of Reach Of Children

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

Instructions For Use

Apply as needed.

Dosage & Administration

Topical skin protectant lotion30% petrolatum

Inactive Ingredient

Water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, strearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth -20, BHT, methylparaben, propyparaben, dimethicone, tocopherol.

* Please review the disclaimer below.