NDC 52000-071 Extra Strength Itch Stopping

Itch Stopping Cream

NDC Product Code 52000-071

NDC CODE: 52000-071

Proprietary Name: Extra Strength Itch Stopping 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: Itch Stopping Cream 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.

NDC Code Structure

  • 52000 - Universal Distribution Centre Llc

NDC 52000-071-02

Package Description: 1 TUBE in 1 CARTON > 35.4 g in 1 TUBE (52000-071-01)

NDC Product Information

Extra Strength Itch Stopping with NDC 52000-071 is a a human over the counter drug product labeled by Universal Distribution Centre Llc. The generic name of Extra Strength Itch Stopping is itch stopping cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Universal Distribution Centre Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Extra Strength Itch Stopping 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g
  • ZINC ACETATE 1 mg/g

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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

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: Universal Distribution Centre Llc
Labeler Code: 52000
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: 01-21-2021 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: 12-31-2022 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.

Extra Strength Itch Stopping Product Label Images

Extra Strength Itch Stopping 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

Uses

  • Temporarily relieves pain and itching associated with:
  • Insect bitesminor burnssunburnminor skin irritationsminor cutsscrapesrashes due to poison ivy, poison oak, and poison sumacdries the oozing and weeping of poison ivy, poison oak, and poison sumac

Other

Drug Facts

Distributed by:

Universal Distribution Centre LLC
96 Distribution Boulevard, Edison

NJ 08817

Otc - Purpose

Active ingredientsPurposeDiphenhydramine hydrochloride 2%Topical analgesicZinc acetate 0.1%Skin protectant

Warnings

For external use only

Otc - Do Not Use

  • Do not useon large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth

Otc - Ask Doctor

  • Ask a doctor before useon chicken poxon measles

Otc - When Using

When using this product


avoid contact with eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or does not improve within 7 dayssymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.


If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Do not use more than directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Other Information

  • Protect from excessive heat (40°C/104°F)

Inactive Ingredients

Cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions?

Call toll-free 1-800-222-1222

* Please review the disclaimer below.