NDC 81383-002 Dr. Dris Hand Sanitizer
Ethyl Alcohol
NDC Product Code 81383-002
Proprietary Name: Dr. Dris Hand Sanitizer 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: Ethyl 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.
NDC Code Structure
- 81383 - Hanson Venture Enterprise Inc
- 81383-002 - Dr. Dris Hand Sanitizer
NDC 81383-002-01
Package Description: 60 mL in 1 BOTTLE
NDC 81383-002-02
Package Description: 240 mL in 1 BOTTLE
NDC 81383-002-03
Package Description: 475 mL in 1 BOTTLE
NDC 81383-002-04
Package Description: 4000 mL in 1 BOTTLE
NDC Product Information
Dr. Dris Hand Sanitizer with NDC 81383-002 is a a human over the counter drug product labeled by Hanson Venture Enterprise Inc. The generic name of Dr. Dris Hand Sanitizer is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.
Labeler Name: Hanson Venture Enterprise Inc
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.
Dr. Dris Hand Sanitizer 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.
- HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
- LAVENDER OIL (UNII: ZBP1YXW0H8)
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- WATER (UNII: 059QF0KO0R)
- COCONUT (UNII: 3RT3536DHY)
- EUCALYPTUS OIL (UNII: 2R04ONI662)
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: Hanson Venture Enterprise Inc
Labeler Code: 81383
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: 03-26-2021 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 - 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.
Dr. Dris Hand Sanitizer Product Label Images
Dr. Dris Hand Sanitizer 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
- Uses
- Warnings
- Otc - Do Not Use
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
Active Ingredient
Ethyl Alcohol 68% v/v
Purpose
Ethyl Alcohol 68% v/v................Antiseptic
Uses
Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Otc - Do Not Use
Do not use:• on children less than 2 months of age
• on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
• store in a cool dry place. Do not overheat.
Inactive Ingredients
Purified Water, Hydroxyethyl Cellulose, Coconut Pulp Extract, Lavender Oil, Eucalyptus Oil, Aloe Vera Leaf Juice,
* Please review the disclaimer below.