NDC 0168-0181 Hydrocortisone

Hydrocortisone

NDC Product Code 0168-0181

NDC CODE: 0168-0181

Proprietary Name: Hydrocortisone 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: Hydrocortisone 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 to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 0168 - E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

NDC 0168-0181-31

Package Description: 1 TUBE in 1 CARTON > 28.35 g in 1 TUBE

NDC Product Information

Hydrocortisone with NDC 0168-0181 is a a human over the counter drug product labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The generic name of Hydrocortisone is hydrocortisone. The product's dosage form is ointment and is administered via topical form.

Labeler Name: E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Hydrocortisone 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.

  • HYDROCORTISONE 10 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

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: E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Labeler Code: 0168
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: 04-06-1975 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2021 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.

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

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]

* Please review the disclaimer below.

Hydrocortisone 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

Active Ingredient (In Each Gram):

Hydrocortisone 10 mg

Purpose:

Anti-itch

Indications & Usage

  • Uses: •for temporary relief of itching associated with minor skin irritations and rashes due to: •eczema •insect bites •soaps and detergents •cosmetics •jewelry •seborrheic dermatitis •psoriasis •poison ivy, oak or sumac •for external genital, feminine and anal itching •other uses of this product should be only under the advice and supervision of a doctor

Warnings

  • Warnings:For external use onlyDo not use •in children under 2 years of age •if you have a vaginal discharge •for the treatment of diaper rashAsk a doctor before use if you have •external genital or feminine itching •external anal itching •bleedingWhen using this product •avoid contact with eyes •do not exceed the recommended daily dosage unless directed by a doctor •do not put this product into the rectum by using fingers or any mechanical device or applicatorStop 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, stop use and do not begin use of any other hydrocortisone product

Keep Out Of Reach Of Children.

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

Dosage & Administration

  • Directions:For minor skin irritations and rashes, •adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.For external anal itching: •adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly •gently dry by patting or blotting with toilet tissue or soft cloth before application of this product •children: under 12 years of age, consult a doctor.

Other

  • Other information: •do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal •store at room temperature •see crimp of tube for Lot Number and Expiration Date

Questions or comments? call toll free 1-800-645-9833E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, NY 11747 W5160B R12/11

Inactive Ingredients

Mineral oil and white petrolatum

* Please review the disclaimer below.