NDC 63940-810 70%
Isopropyl Alcohol Liquid Topical

Product Information

Product Code63940-810
Proprietary Name 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.
70%
Non-Proprietary Name 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.
Isopropyl Alcohol
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Liberty Procurement, Inc
Labeler Code63940
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-18-2009
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 63940-810-17

Package Description: 473 mL in 1 BOTTLE, SPRAY

NDC 63940-810-43

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 63940-810-45

Package Description: 946 mL in 1 BOTTLE, PLASTIC

Product Details

70% is a human over the counter drug product labeled by Liberty Procurement, Inc. The generic name of 70% is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.


What are 70% Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)


* Please review the disclaimer below.

70% Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Isopropyl alcohol 70%


Purpose



First Aid Antiseptic


Use



helps prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

Warnings



For external use only


Flammable



Keep away from fire or flame, heat, spark, electrical


Ask A Doctor Before Use



for deep or puncture wounds, animal bites or serious burns


When Using This Product



  • do not get into eyes
  • do not inhale
  • do not apply over large areas of the body
  • do not use longer than 1 week

Stop Use And Ask A Doctor



If condition persists or gets worse


Keep Out Of Reach Of Children



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


Caution



Fumes can be acutely irritating to skin, eyes and the respiratory system.  Do not apply to irritated skin or if excessive irritation develops.  Avoid getting into the eyes or on mucous membranes.  Avoid inhaling this product.


Directions



  • clean the affected area
  • apply a small amount of this product on the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other Information



  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • will produce serious gastric disturbances if taken internally

Inactive Ingredient



water


Adverse Reactions



Distributed by Liberty Procurement, Inc

650 Liberty Ave., Union, NJ 07083 USA

Visit us at:www.facevalues.com


Package Label



CORE VALUES

Isopopyl

Rubbing

Alcohol

  • First aid antiseptic
  • For rubbing & massaging
  • WARNING FLAMMABLE  - Keep away from heat, spark, electrical, fire or flame

    CAUTION: Do not point at self or others; product will squirt when squeezed.

    Use only in a well-ventilated area; fumes may be harmful.

    16 FL OZ (1 PT) 473 mL


* Please review the disclaimer below.