NDC 69394-003 Gel Hand Sanitizer Coconut Scent
80% Alcohol Solution
NDC Product Code 69394-003
Proprietary Name: Gel Hand Sanitizer Coconut Scent 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: 80% Alcohol Solution 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.
NDC Code Structure
- 69394 - Aakron Rule Corporation
- 69394-003 - Gel Hand Sanitizer
NDC 69394-003-01
Package Description: 3785 mL in 1 BOTTLE, PLASTIC
NDC Product Information
Gel Hand Sanitizer Coconut Scent with NDC 69394-003 is a a human over the counter drug product labeled by Aakron Rule Corporation. The generic name of Gel Hand Sanitizer Coconut Scent is 80% alcohol solution. The product's dosage form is gel and is administered via topical form.
Labeler Name: Aakron Rule Corporation
Dosage Form: Gel - 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.
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.
Gel Hand Sanitizer Coconut Scent 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.
- GLYCERIN (UNII: PDC6A3C0OX)
- WATER (UNII: 059QF0KO0R)
- RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
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: Aakron Rule Corporation
Labeler Code: 69394
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: 02-08-2021 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: 12-31-2022 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 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. Values = ‘Y’ or ‘N’.
* Please review the disclaimer below.
Gel Hand Sanitizer Coconut Scent Product Label Images
Gel Hand Sanitizer Coconut Scent 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
- Active Ingredient
- Purpose
- Use
- Warnings
- Do Not Use
- When Using
- Stop Use
- Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
- Hand Sanitizer Gel, Coconut Scent, 1 Gallon (3.785 L) - Package Label
Active Ingredient
Active IngredientEthyl alcohol 80% v/v
Purpose
PurposeAntiseptic, Hand Sanitizer
Use
UseHand sanitizer to decrease bacteria on the skin that could cause disease.For use when soap and water are not available.
Warnings
WarningsFor external use only: hands
Flammable. Keep away from heat or flame.
Do Not Use
Do not use• on children less than 2 months of age• on open skin wounds
When Using
When usingWhen using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use
Stop useStop use and ask a doctor if irritation or rash occurs and lasts.
Keep Out Of Reach Of Children
Keep out of reach of childrenKeep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away
Directions
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
Other information
• Do not store above 115°F
• May discolor some fabrics.
• May damage wood finishes or plastics.
Inactive Ingredients
Inactive ingredients
Fragrance, Glycerin, PEG-6 (and) AMP-acrylates/vinyl isodecanoate crosspolymer, purified water
Hand Sanitizer Gel, Coconut Scent, 1 Gallon (3.785 L) - Package Label
AAkron Line - Gel Hand Sanitizer - Coconut Scent - NDC 69394-003-01
* Please review the disclaimer below.
