NDC 81314-302 Wancare Antiviral Wipes With Alcohol

Ethyl Alcohol

NDC Product Code 81314-302

NDC 81314-302-01

Package Description: 15 PACKAGE in 1 PACKET > 1.821 mL in 1 PACKAGE

NDC 81314-302-02

Package Description: 25 PACKAGE in 1 PACKET > 2.345 mL in 1 PACKAGE

NDC 81314-302-03

Package Description: 60 PACKAGE in 1 PACKET > 2.345 mL in 1 PACKAGE

NDC 81314-302-04

Package Description: 100 PACKAGE in 1 PACKET > 2.345 mL in 1 PACKAGE

NDC 81314-302-05

Package Description: 40 PACKAGE in 1 CANISTER > 3.678 mL in 1 PACKAGE

NDC 81314-302-06

Package Description: 75 PACKAGE in 1 CANISTER > 3.678 mL in 1 PACKAGE

NDC 81314-302-07

Package Description: 120 PACKAGE in 1 CANISTER > 3.678 mL in 1 PACKAGE

NDC 81314-302-08

Package Description: 160 PACKAGE in 1 CANISTER > 3.678 mL in 1 PACKAGE

NDC 81314-302-09

Package Description: 240 PACKAGE in 1 PAIL > 3.678 mL in 1 PACKAGE

NDC 81314-302-10

Package Description: 400 PACKAGE in 1 PAIL > 3.678 mL in 1 PACKAGE

NDC Product Information

Wancare Antiviral Wipes With Alcohol with NDC 81314-302 is a a human over the counter drug product labeled by Kaf Grup Saglik Hizmetleri Insaat Sanayi Ve Ticaret Limited Sirketi. The generic name of Wancare Antiviral Wipes With Alcohol is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kaf Grup Saglik Hizmetleri Insaat Sanayi Ve Ticaret Limited Sirketi

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.

Wancare Antiviral Wipes With Alcohol 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 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Kaf Grup Saglik Hizmetleri Insaat Sanayi Ve Ticaret Limited Sirketi
Labeler Code: 81314
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: 03-20-2020 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: 12-31-2022 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.

Wancare Antiviral Wipes With Alcohol 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)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use(S)

• Hand Sanitizer wet wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.• Recommended for repeated use.

Warnings

For external use only.Flammable. Keep away from heat, fire, sparks or flame.Do not use• in children less than 2 months of age• on open skin woundsWhen using if swallowed, rinse mouth with plenty of water.  Get medical advice, If in eyes, remove contact lenses immediately. Rinse your eyes with plenty of clean water. Get medical attention if symptoms persist.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, get medical help or contact a Poison Control Center right away.

Directions

• Open the cap and remove enough wipes from inside. Wipe your hands gently with the wipes. Discard properly after use. • Close the lid to keep the wipes moist.• No rinse required after use.• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Store between 5-30C (41 -86F)• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin, Fragrance (Perfume), Water.

* Please review the disclaimer below.