NDC 78627-206 Alcohol Wet Wipes

Alcohol Wet Wipes

NDC Product Code 78627-206

NDC 78627-206-01

Package Description: 5 g in 1 PACKET

NDC Product Information

Alcohol Wet Wipes with NDC 78627-206 is a a human over the counter drug product labeled by Suzhou Borage Medical Technology Co.,ltd.. The generic name of Alcohol Wet Wipes is alcohol wet wipes. The product's dosage form is swab and is administered via extracorporeal; topical form.

Labeler Name: Suzhou Borage Medical Technology Co.,ltd.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Alcohol Wet 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 67.8246 g/100g

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.

  • Extracorporeal - Administration outside of the body.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Extracorporeal - Administration outside of the body.
  • 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: Suzhou Borage Medical Technology Co.,ltd.
Labeler Code: 78627
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: 06-01-2020 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.

Alcohol Wet Wipes Product Label Images

Alcohol Wet 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

Otc - Active Ingredient

Alcohol 75% by volume................Antiseptic

Indications & Usage

For hand washing to decrease bacteria on the skin.Apply topically to the skin to help prevent cross contamination.

Warnings

  • Flammable, keep away from fire or flame.For external only.When using this product do not use in or near the eyes. In case of contact. rinse eyes throughly with water.Stop and ask doctor If irritation or rash appears and lasts.Keep this out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

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

Otc - Purpose

For hand washing to decrease bacteria on the skin.

Dosage & Administration

  • Tear open packetOpen and unfold wipeThoroughly wipe hands, fingers and wrists.Discard after single use.

Inactive Ingredient

Water

* Please review the disclaimer below.