NDC 36800-524 Topcare Hydrocortisone

Hydrocortisone

NDC Product Code 36800-524

NDC CODE: 36800-524

Proprietary Name: Topcare 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

NDC 36800-524-26

Package Description: 2 TUBE in 1 CARTON > 56 g in 1 TUBE

NDC 36800-524-64

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Topcare Hydrocortisone with NDC 36800-524 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Hydrocortisone is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Topco Associates 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.

Topcare 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 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.

  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.
  • 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: Topco Associates Llc
Labeler Code: 36800
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: 02-14-2020 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 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.

Topcare 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

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do Not Use

  • •in the genital area if you have a vaginal discharge. Consult a doctor. •for the treatment of diaper rash. Consult a doctor.

When Using This Product

  • •avoid contact with the eyes •do not use more than directed unless told to do so by a doctor •do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • •condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor •rectal bleeding occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •for itching of skin irritation, inflammation, and rashes: •adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily •children under 2 years of age: do not use, consult a doctor •for external anal and genital itching, adults: •when practical, clean the affected area with mild soap and warm water and rinse thoroughly •gently dry by patting or blotting with toilet tissue or a soft cloth before applying •apply to affected area not more than 3 to 4 times daily •children under 12 years of age: consult a doctor

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients

Water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, aloe barbadensis leaf juice

* Please review the disclaimer below.