NDC 71810-103 Workmans Friend Superior Isopropyl Rubbing Alcohol

Isopropyl Rubbing Alcohol

NDC Product Code 71810-103

NDC CODE: 71810-103

Proprietary Name: Workmans Friend Superior Isopropyl Rubbing Alcohol 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 Rubbing 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

  • 71810 - Solvchem, Inc
    • 71810-103 - Workmans Friend Superior Isopropyl Rubbing Alcohol

NDC 71810-103-10

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Workmans Friend Superior Isopropyl Rubbing Alcohol with NDC 71810-103 is a a human over the counter drug product labeled by Solvchem, Inc. The generic name of Workmans Friend Superior Isopropyl Rubbing Alcohol is isopropyl rubbing alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Solvchem, Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Workmans Friend Superior Isopropyl Rubbing 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.

  • ISOPROPYL ALCOHOL 91 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: Solvchem, Inc
Labeler Code: 71810
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: 01-01-2021 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.

Workmans Friend Superior Isopropyl Rubbing Alcohol Product Label Images

Workmans Friend Superior Isopropyl Rubbing 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)

Isopropyl Alcohol 91% v/v. Purpose: First Aid Antiseptic

Purpose

First Aid Antiseptic

Use

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

Warnings

For external use only.Flammable, keep away from flame and fire, heat, spark or electricity.Use only in well-ventilated area; fumes may be harmful

Otc - When Using

When using this productDo not get in eyes.Do not apply over large areas of the body.Do not use longer than one week unless directed by a doctor.

Otc - Stop Use

Stop use and ask a doctor if condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • Clean affected area.Apply small amount of this product on the area 1-3 times daily.May be covered with a sterile bandage.If bandaged, let dry first.

Other Information

  • If taken internally, serious gastric disturbances will result.Store at room termperature.Does not contain, nor is intended as a substitute for grain or ethyl alcohol.

Inactive Ingredients

Purified water

* Please review the disclaimer below.