NDC 80671-004 Edu San

Ethyl Alcohol

NDC Product Code 80671-004

NDC 80671-004-50

Package Description: 50 PACKAGE in 1 PACKET > 7.8 mL in 1 PACKAGE

NDC Product Information

Edu San with NDC 80671-004 is a a human over the counter drug product labeled by Quanzhou Aiwina Hygiene Products Co.,ltd. The generic name of Edu San is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Quanzhou Aiwina Hygiene Products Co.,ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Edu San 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.

  • ALCOHOL 72 mL/100mL

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: Quanzhou Aiwina Hygiene Products Co.,ltd
Labeler Code: 80671
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: 03-12-2021 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".

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Edu San Product Label Images

Edu San 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

Ethyl alcohol 72 % v/v




• hand wipes to decrease bacteria on the skin• recommended for repeated use• for use when soap and water are not available


Flammable, keep away from fire/flameFor external use onlyDo not use• in children less than 2 months of age• on open skin wounds• on wood surfaces or glasses, utensils or dishesWhen using this product• do not get into eyes. In case of contact, rinse eyes thoroughly with water• avoid touching face and eyes• contact lenses to be removed after the first 5 minutes and rinsedStop use and ask a doctor if• irritation and redness develop• condition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


• pull the tab on the cover and pull the first sheet through the center slits• wet hands thoroughly with product and allow to dry without wiping• safely discard the wipe after use. Do not flush• always close the lid well (you should hear a snap) between uses to avoid any loss of moisture• always use a fresh wipe• supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store below 86°F(30°C)• may discolor certain fabrics, keep away from sunlight• avoid freezing and excessive heat above 40⁰C (104⁰F)• container should not be reused in any way and should be disposed of safely

Inactive Ingredients

Aloe vera (Aloe barbadensis ) leaf extract, benzalkonium chloride, betaine, dl-alpha-tocopherol, glycerin, iodopropynyl butylcarbamate,propanediol, water

Questions? +1-802-649-6998

You may also report serious side effects to this phone number.EST: 8:00 AM - 6:00 PM, Mon-Fri

* Please review the disclaimer below.