NDC 10565-007 Isopropyl Alcohol With Wintergreen 50%
Solution Topical

Product Information

What is NDC 10565-007?

The NDC code 10565-007 is assigned by the FDA to the product Isopropyl Alcohol With Wintergreen 50% which is a human over the counter drug product labeled by Hydrox Laboratories. The product's dosage form is solution and is administered via topical form. The product is distributed in 5 packages with assigned NDC codes 10565-007-04 118 ml in 1 bottle, plastic , 10565-007-08 237 ml in 1 bottle, plastic , 10565-007-16 473 ml in 1 bottle, plastic , 10565-007-32 946 ml in 1 bottle, plastic , 10565-007-99 3785 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code10565-007
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.		Isopropyl Alcohol With Wintergreen 50%
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 With Wintergreen 50%
Substance Name What is the Substance Name?
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.		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
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.		Hydrox Laboratories
Labeler Code10565
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.		06-19-2019
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

Product Packages

NDC Code 10565-007-04

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC Code 10565-007-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC Code 10565-007-16

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Code 10565-007-32

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC Code 10565-007-99

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

Product Details

What are Isopropyl Alcohol With Wintergreen 50% Active Ingredients?

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.

Isopropyl Alcohol With Wintergreen 50% Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Isopropyl Alcohol With Wintergreen 50% Inactive Ingredients UNII Codes

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.

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Isopropyl Alcohol With Wintergreen 50% Product Label

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.

Product Label Table of Contents



Drug Facts



Active Ingredient

Isopropyl Alcohol 50%


Inactive Ingredient



FD&C Blue No. 1, FD&C Yellow No. 5, Methyl Salicylate, PEG-75 Lanolin, Purified Water


Principal Display Panel



isopropylalcohol - Isopropylalcohol

isopropylalcohol - Isopropylalcohol

Hydrox

Isopropyl Alcohol 50% with Wintergreen

A cooling and refreshing and massaging compound

First Aid Antiseptic

TAMPER EVIDENT CAP FOR YOUR PROTECTION.  IF RING-BAND IS DETACHED FROM CAP OR MISSING, DO NOT USE.

WARNING: FLAMMABLE!

Hydrox Laboratories

Elgin, IL 60123

isopropylalcohol - Isopropylalcohol

isopropylalcohol - Isopropylalcohol

isopropylalcohol - Isopropylalcohol

isopropylalcohol - Isopropylalcohol


* Please review the disclaimer below.