NDC 77093-300 Rubbing Alcohol 70% Isopropyl

70% Rubbing Alcohol

NDC Product Code 77093-300

NDC 77093-300-01

Package Description: 3.78 L in 1 JUG

NDC 77093-300-02

Package Description: 18.92 L in 1 PAIL

NDC 77093-300-03

Package Description: 208.19 L in 1 DRUM

NDC 77093-300-04

Package Description: 1040.98 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC 77093-300-05

Package Description: 1249.19 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Product Information

Rubbing Alcohol 70% Isopropyl with NDC 77093-300 is a a human over the counter drug product labeled by Vincit Zee. The generic name of Rubbing Alcohol 70% Isopropyl is 70% rubbing alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Vincit Zee

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 70% Isopropyl 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 .7 L/L

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: Vincit Zee
Labeler Code: 77093
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: 05-08-2020 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 70% Isopropyl 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

Otc - Active Ingredient

Isopropyl Alcohol 70% v/v

Otc - Purpose

First aid antiseptic

Indications & Usage

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

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns

Warnings

  • For external use onlyflammable, keep away from heat or flameif taken internally serious gastric disturbances will result

Otc - Stop Use

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

Otc - When Using

  • Do not get into eyesdo not apply over large areas of the bodydo not use longer than one week unless directed by a doctor

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 immediately.

Dosage & Administration

  • Clean affected areaapply small amount of this product on the area 1-3 times dailyif bandaged, let dry firstmay be covered with a sterile bandage

Storage And Handling

  • Store at room temperatureDoes not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive Ingredient

Purified water

* Please review the disclaimer below.