NDC 0225-0516 Itch-x

Pramoxine Hcl/benzyl Alcohol Spray Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0225-0516
Proprietary Name:
Itch-x
Non-Proprietary Name: [1]
Pramoxine Hcl/benzyl Alcohol
Substance Name: [2]
Benzyl Alcohol; Pramoxine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Bf Ascher And Co Inc
    Labeler Code:
    0225
    FDA Application Number: [6]
    part348
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    09-19-2014
    End Marketing Date: [10]
    10-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0225-0516-51

    Package Description: 59.1 mL in 1 BOTTLE, SPRAY

    Price per Unit: $0.07036 per ML

    Product Details

    What is NDC 0225-0516?

    The NDC code 0225-0516 is assigned by the FDA to the product Itch-x which is a human over the counter drug product labeled by Bf Ascher And Co Inc. The generic name of Itch-x is pramoxine hcl/benzyl alcohol. The product's dosage form is spray and is administered via topical form. The product is distributed in a single package with assigned NDC code 0225-0516-51 59.1 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Itch-x?

    Uses temporarily relieves pain and itching associ- ated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

    What are Itch-x 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.
    • BENZYL ALCOHOL 10 g/100mL - A colorless liquid with a sharp burning taste and slight odor. It is used as a local anesthetic and to reduce pain associated with LIDOCAINE injection. Also, it is used in the manufacture of other benzyl compounds, as a pharmaceutic aid, and in perfumery and flavoring.
    • PRAMOXINE HYDROCHLORIDE 1 g/100mL

    Which are Itch-x UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Itch-x 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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Itch-x?

    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:
    • RxCUI: 1293635 - benzyl alcohol 10 % / pramoxine HCl 1 % Topical Spray
    • RxCUI: 1293635 - benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
    • RxCUI: 1293637 - Itch-X 10 % / 1 % Topical Spray
    • RxCUI: 1293637 - benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 10 MG/ML Topical Spray [Itch-X]
    • RxCUI: 1293637 - Itch-X (benzyl alcohol 10 % / pramoxine hydrochloride 1 % ) Topical Spray

    Which are the Pharmacologic Classes for Itch-x?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Benzyl Alcohol Topical


    Benzyl alcohol lotion is used to treat head lice (small insects that attach themselves to the skin) in adults and children 6 months of age and older. It should not be used in children less than 6 months of age. Benzyl alcohol is in a class of medications called pediculicides. It works by killing the lice. Benzyl alcohol lotion will not kill lice eggs, so the medication must be used a second time to kill the lice that may hatch from these eggs.
    [Learn More]


    Pramoxine


    Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [12] 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".