NDC 80213-121 Alcohol Sterilized Wipes

Alcohol

NDC Product Code 80213-121

NDC 80213-121-50

Package Description: 100 CLOTH in 1 PACKET

NDC Product Information

Alcohol Sterilized Wipes with NDC 80213-121 is a a human over the counter drug product labeled by Zhejiang Chenwei Daily Chemicals Technology Co.,ltd.. The generic name of Alcohol Sterilized Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Zhejiang Chenwei Daily Chemicals Technology 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.

Alcohol Sterilized 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 3.3 mL/1

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)
  • POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)
  • DIRECT BLACK 19 (UNII: B91N7SNH1C)

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: Zhejiang Chenwei Daily Chemicals Technology Co.,ltd.
Labeler Code: 80213
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: 08-25-2020 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 Sterilized Wipes Product Label Images

Alcohol Sterilized 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: Antiseptic

Purpose

TO CLEAN, DEODORIZE & SANITIZE

Warnings

IF IMPROPERLY USED, THIS PRODUCT MAY POSE HAZARDS TO HUMANS AND DOMESTIC ANIMALS.Please follow these safe usage instructions.

Do Not Use

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

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 reach of children.If swallowed, seek medical help or contact a Poison Control Center immediately.

Indications & Usage

Wipe surface and allow surface to remain wet for 15 seconds and allow surface to dry. Discard used wipe in trash. Do not flush in toilet.

Dosage & Administration

Wipe surface and allow surface to remain wet for 15 seconds and allow surface to dry. Discard used wipe in trash. Do not flush in toilet.

Otc - When Using

When using this product, avoid contact with eyes.If contact occurs, rinse eyes thoroughly with water.

Storage And Disposal

Store in original container in areas inaccessible to children.Keep container securely closed in dark, dry area.Properly dispose of used wipes in trash. Do not flush.

Inactive Ingredient

Water, Polyester, Viscose

* Please review the disclaimer below.