NDC 68121-002 Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen

Isopropyl Alcohol

NDC Product Code 68121-002

NDC CODE: 68121-002

Proprietary Name: Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen 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

  • 68121 - Patcos Cosmetics (india) Private Limited
    • 68121-002 - Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen

NDC 68121-002-01

Package Description: 354.8 mL in 1 BOTTLE

NDC Product Information

Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen with NDC 68121-002 is a a human over the counter drug product labeled by Patcos Cosmetics (india) Private Limited. The generic name of Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Patcos Cosmetics (india) Private Limited

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.

Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen 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 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)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • LANETH-75 (UNII: QQ4C4Q56ST)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Patcos Cosmetics (india) Private Limited
Labeler Code: 68121
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: 12-30-2020 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.

Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen Product Label Images

Pharmacy Prescription 70% Isopropyl Alcohol With Wintergreen 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

Extra Information On Front Label :

  • FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burnsWARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmfulCAUTION : Do not point at self or others, product will squirt when squeezed

Active Ingredients

Isopropyl Alcohol 70%

Purpose

First Aid Antiseptic

Uses

  • First aid to help prevent the risk of infection inMinor cutsScrapesBurns

Warnings

  • For external use onlyIf taken internally serious gastric disturbances will result.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 area of the body ,do not use longer than 1 week.Stop use and ask a doctor if condition persist or get worse.Keep out of reach of childrenIf 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 eyes or mucus membranes .Avoid inhaling this product.

Directions

  • Clean the affected area.Apply a small amount of this product on the area 1 to 2 times daily.May be covered with a sterile bandage.If bandaged lets dry first.

Other Information

  • Does not contain ,nor is intended as a substitute for grain or ethyl alcohol.Tamper Evident : Do not use if the under cap safety foil is broken or missing.

Inactive Ingredients

  • Water ( Aqua)Methyl SalicylateLaneth -75FD and C Blue #1FD AND C YELLOW #5

* Please review the disclaimer below.