NDC 78183-005 Biopure 75% Alcohol Wipes

Biopure Alcohol Wipes

NDC Product Code 78183-005

NDC 78183-005-01

Package Description: 100 U in 1 CANISTER

NDC Product Information

Biopure 75% Alcohol Wipes with NDC 78183-005 is a a human over the counter drug product labeled by Kunming Ansheng Industry & Trade Co., Ltd.. The generic name of Biopure 75% Alcohol Wipes is biopure alcohol wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kunming Ansheng Industry & Trade 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.

Biopure 75% Alcohol Wipes 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 .75 U/U

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.
  • 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: Kunming Ansheng Industry & Trade Co., Ltd.
Labeler Code: 78183
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: 07-13-2020 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 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.

Biopure 75% Alcohol Wipes Product Label Images

Biopure 75% Alcohol Wipes 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(S)

Alcohol 75% v/v.

Purpose

Antibacterial;

Use

Hand sanitizer to help reduce bacterial that potentially casue disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product do not use in or contact the 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 sign of serious condition.

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.

Directions

  • Apply to hands, allow to air dry without wiping.Discard wipe in trash receptable after use.Do not flush.

Inactive Ingredients

Pure water; Spunlace Non-woven Fabric;

Other Information

  • Keep in cool, dry place, between 15-30℃ (59-86℉).Avoid freezing and excessive heat above 40℃ (104℉).

* Please review the disclaimer below.