NDC 46122-331 Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil

Isopropyl Alcohol

NDC Product Code 46122-331

NDC CODE: 46122-331

Proprietary Name: Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil 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

  • 46122 - Amerisource Bergen
    • 46122-331 - Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil

NDC 46122-331-43

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil with NDC 46122-331 is a a human over the counter drug product labeled by Amerisource Bergen. The generic name of Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Amerisource Bergen

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil 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 700 mg/mL

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.

  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • 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: Amerisource Bergen
Labeler Code: 46122
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: 01-01-2016 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 - 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.

Gnp Isopropyl Alcohol 70 Percent With Wintergreen Oil 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

Isopropyl Alcohol 70% by volume

Purpose

First aid antiseptic

Use

  • First aid to help prevent the risk of infection in.minor cuts
  • Scrapes
  • Burns

Warnings

  • For external use only.Flammable, keep way from spark, heat and flame.
  • Use in well ventilated area, fumes may be harmful.

Ask A Doctor Before Use For

  • Deep wounds
  • Animal bites
  • Serious burns

When Using This Product

  • Do not get into eyes or mucous membranes.
  • Do not apply to irritated skin.

Stop Use And Ask A Doctor If

Excessive irritation of the skin develops.

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Apply freely and rub briskly with hands or towel.

Other Information

  • Does not contain ethyl or grain alcohol and is not sold as a substitute for preparations containing the same.
  • Store at controlled room temperature
  • Will produce serious gastric disturbances if taken internally.

Inactive Ingredient

Methyl salicylate 0.5%FDC Blue #1FDC Yellow #5purified water

* Please review the disclaimer below.