NDC 73592-050 Rubbing Alcohol 50%

Isopropyl Alcohol

NDC Product Code 73592-050

NDC 73592-050-12

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Rubbing Alcohol 50% with NDC 73592-050 is a a human over the counter drug product labeled by Hind Pharma. The generic name of Rubbing Alcohol 50% is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Hind Pharma

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.

Rubbing Alcohol 50% 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 50 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.
  • 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: Hind Pharma
Labeler Code: 73592
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: 03-05-2020 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.

Rubbing Alcohol 50% Product Label Images

Rubbing Alcohol 50% 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 Ingredients:

Isopropyl alcohol 50% concentrate

Otc - Purpose

For antimicrobial topical use.

Uses:

As a first aid to help prevent the risk of infection in minor cuts, scrapes & burns.

Warning:

  • Flammable!Keep the product away from direct sunlight, heat, flame/fire, spark and electricity.Do not use as a substitute of ethyl alcohol or grain.Not for medicinal usePregnant or nursing mothers must prefer consulting the doctor before usage.For external use only. Stop using if any irritation/ Pin or swelling occurs.Emergency/ First aid:In case of direct contact of;Eyes: Wash the eyes with fresh water for 25 minutes and seek medical assistance. Skin: Wash with soap and water. Consult doctor if irritation persists.Inhalation: Move to fresh air

Otc - Keep Out Of Reach Of Children

Keep away from children. In case of accidental ingestion, seek assistance or rush to Poison control center immediately.

Direction:

  • Use a clean swab, cotton or gauze to apply on the skin directly.Use clean hands for the purpose of rubbing.

Inactive Ingredients:

Purified water

* Please review the disclaimer below.