NDC 36800-508 Clotrimazole

Clotrimazole

NDC Product Code 36800-508

NDC CODE: 36800-508

Proprietary Name: Clotrimazole 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: Clotrimazole 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.

  • Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

NDC Code Structure

  • 36800 - Top Care (topco Associates Llc)

NDC 36800-508-01

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

NDC Product Information

Clotrimazole with NDC 36800-508 is a a human over the counter drug product labeled by Top Care (topco Associates Llc). The generic name of Clotrimazole is clotrimazole. The product's dosage form is cream and is administered via vaginal form.

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.

Clotrimazole 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.


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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.

Product Labeler Information

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

Labeler Name: Top Care (topco Associates Llc)
Labeler Code: 36800
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-30-2021 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 - 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.

Clotrimazole 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 Ingredients

Clotrimazole, USP 1%)

Purpose

Antifungal

Uses

  • Treats most athlete's foot, jock itch, and ringwormrelieves itching, burning, cracking, scaling, and discomfort

Warnings

For external use only

Do Not Use

On children under 2 years of age, unless directed by a doctor.

When Using This Product,

Avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • Irritation occursthere is no improvement within 4 weeks (for athlete's foots and ringworm) or within 2 weeks (for jock itch)

Keep Out Of Reach Of Children

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

Directions

  • Wash the affected area and dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition lasts longer, contact a doctorthis product is not effective on the scalp or nails

Other Information

  • Store at room temperature 20º-25ºC (68º-77ºF)before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

Benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Package Label

TOPCARE HEALTH Athlete's Foot Cream

* Please review the disclaimer below.