NDC 12745-106 Isopropyl Alcohol

Isopropyl Alcohol

NDC Product Code 12745-106

NDC 12745-106-01

Package Description: 3785 mL in 1 CONTAINER

NDC Product Information

Isopropyl Alcohol with NDC 12745-106 is a a human over the counter drug product labeled by Medical Chemical Corporation. The generic name of Isopropyl Alcohol is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Medical Chemical Corporation

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.

Isopropyl 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 70.14 g/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.
  • 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: Medical Chemical Corporation
Labeler Code: 12745
FDA Application Number: part344 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 10-30-2020 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: 12-31-2021 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.

Isopropyl Alcohol Product Label Images

Isopropyl 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

Purpose

Antiseptic

Uses

Use as a general purpose topical antiseptic and massage lubricant.

Active Ingredient

Isopropyl Alcohol, 70%

Directions

Apply directly to skin. Discontinue use and consult a physician if irritation, redness or infection develops. Keep out of reach of children.

Warnings

Danger: Highly flammable liquid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. Wear protective clothes and eye protection. In case of fire, use fire extinguishers approved for alcohol fires.

Other Information

Keep tightly closed and protected from light. Store at room temperature. For external use only. Does not contain ethyl alcohol. In case of ingestion contact a poison control center.

Inactive Ingredient

Inactive Ingredients: Water

Dosage & Administration

Directions:  Apply to affected area for first-aid treatment of minor cuts and abrasions.  In case of deep or puncture wounds consult a physician.  Discontinue use and get medical aid if redness, irritation or infection develops.  Apply liberally for rubbing.

* Please review the disclaimer below.