NDC 44224-0010 Easy Care First Aid Skin Cleansing Alcohol Wipe

Isopropyl Alcohol

NDC Product Code 44224-0010

NDC Code: 44224-0010

Proprietary Name: Easy Care First Aid Skin Cleansing Alcohol Wipe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Isopropyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44224 - Tender Corporation
    • 44224-0010 - Easy Care First Aid Skin Cleansing Alcohol Wipe

NDC 44224-0010-0

Package Description: .5 mL in 1 POUCH

NDC Product Information

Easy Care First Aid Skin Cleansing Alcohol Wipe with NDC 44224-0010 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Easy Care First Aid Skin Cleansing Alcohol Wipe is isopropyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Tender Corporation

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.

Easy Care First Aid Skin Cleansing Alcohol Wipe 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.

  • ISOPROPYL ALCOHOL 70 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: Tender Corporation
Labeler Code: 44224
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: 07-01-2019 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: 12-31-2020 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.

Easy Care First Aid Skin Cleansing Alcohol Wipe Product Label Images

Easy Care First Aid Skin Cleansing Alcohol Wipe 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

Active Ingredient:                                





Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

For preparation of skin before injection.

Warnings

For external use only.Flammable - keep away from fire or flame

Keep Out Of Reach Of Children.

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

Do Not Use

  • In the eyeswith electrocautery procedures

Stop Use And Ask A Doctor If

  • Irritation and redness developcondition persists for more than 72 hours

Other Information

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Directions

Wipe Injection site vigorously and discard.

Inactive Ingredient

Purified water.

* Please review the disclaimer below.