NDC 69250-661 Alcohol Prep Pad

Alcohol Prep Pad

NDC Product Code 69250-661

NDC 69250-661-02

Package Description: 200 mL in 1 BOX

NDC Product Information

Alcohol Prep Pad with NDC 69250-661 is a a human over the counter drug product labeled by Biomed Resource Inc.. The generic name of Alcohol Prep Pad is alcohol prep pad. The product's dosage form is sponge and is administered via topical form.

Labeler Name: Biomed Resource Inc.

Dosage Form: Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.

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 Prep Pad 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 7 mL/10mL

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: Biomed Resource Inc.
Labeler Code: 69250
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-30-2014 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 Prep Pad Product Label Images

Alcohol Prep Pad 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

Alcohol Prep Pad

70% Isoprppyl Alcohol

Otc - Purpose

Antispectic. For preparation of skin prior of injection.

Otc - Keep Out Of Reach Of Children

In case of accidental ingestion, contact your phisician or Poison Control Center right away.

Otc - Do Not Use

Do not use with electrocautery procedures.

Inactive Ingredient

Purified water.

Dosage & Administration

One piece at the time, Discard after use.

Indications & Usage

Wipe injection site vigorously.Discard after use.

Warnings

1. For external use only;2. Flammable. Keep away from heat or flame;3. Aviod to contact eyes. Flush throoughly with water in case of contact;4. Stop use if irritation or redness develop;5. Do not use with electrocautery procedures;Keep out of reach of children.

* Please review the disclaimer below.