NDC 0225-0495 Itch X

Benzyl Alcohol/pramoxine Hydrochloride

NDC Product Code 0225-0495

NDC 0225-0495-33

Package Description: 35.4 g in 1 TUBE

NDC Product Information

Itch X with NDC 0225-0495 is a a human over the counter drug product labeled by Bf Ascher And Co Inc. The generic name of Itch X is benzyl alcohol/pramoxine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Bf Ascher And Co Inc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Itch X 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.

  • BENZYL ALCOHOL 10 g/100g
  • PRAMOXINE HYDROCHLORIDE 1 g/100g

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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALOE (UNII: V5VD430YW9)
  • WATER (UNII: 059QF0KO0R)
  • EDETOL (UNII: Q4R969U9FR)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Bf Ascher And Co Inc
Labeler Code: 0225
FDA Application Number: part348 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: 09-19-2014 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 - NO 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".

* Please review the disclaimer below.

Information for Patients

Benzyl Alcohol Topical

Benzyl Alcohol Topical is pronounced as (ben' zil al' ka hol)

Why is benzyl alcohol topical medication prescribed?
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 use...
[Read More]
Pramoxine

Pramoxine is pronounced as (pra mox' een)
Why is pramoxine medication prescribed?
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...
[Read More]

* Please review the disclaimer below.

Itch X Product Label Images

Itch X 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

Active ingredients......................................PurposeBenzyl alcohol 10%......................................Topical analgesic

Pramoxine hydrochloride 1%.......................Topical analgesic

Indications & Usage

UseFor temporarily relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

Otc - Purpose

UseTemporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Warnings

  • WarningsFor external use only.Avoid contact with eyes.

Otc - Do Not Use

  • Do not useon open wounds, damaged, or blistered skin.for vaginal, genital, or rectal itching.on children under 2 years of age unless under the advice and supervision of a physician.

Otc - Ask Doctor

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

Dosage & Administration

  • Directionsadults and children 2 years and older - apply to affected area not more than 3 or 4 times dailychildren under 2 years - consult a physician

Storage And Handling

  • Other informationstore at 59°-86° F (15°-30° C) in a dry placemfd. in the USA for B.F. Ascher & Co., Inc.

Inactive Ingredient

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, diazolidinyl urea, methylparaben, propylene glycol, propylparaben, SD alcohol 40, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

Otc - Questions

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit
www.bfascher.com

* Please review the disclaimer below.