NDC 50382-025 Clotrimazole

Clotrimazole

NDC Product Code 50382-025

NDC CODE: 50382-025

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

  • 50382 - Galentic Pharma (india) Private Limited

NDC 50382-025-13

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

NDC Product Information

Clotrimazole with NDC 50382-025 is a a human over the counter drug product labeled by Galentic Pharma (india) Private Limited. The generic name of Clotrimazole is clotrimazole. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 309367.

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.

  • CETETH-20 (UNII: I835H2IHHX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)

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: Galentic Pharma (india) Private Limited
Labeler Code: 50382
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: 08-07-2013 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.

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 Ingredient

Active IngredientClotrimazole 1.0%

Purpose

Antifungal

• Uses

  • Cures most athlete's foot, jock itch and ringwormRelieves itching, burning, cracking, scaling and discomfort which accompany these conditions

• Warnings

  • For external use only.

Otc - Do Not Use

  • Do not use:Do not use on children under 2 years of age unless directed by a doctor.

• Stop Use And Ask Doctor If

  • Irritation occursThere is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Otc - Keep Out Of Reach Of Children

  • KEEP OUT Of REACH Of CHILDRENIf swallowed, get medical help or contact a Poison Control Center immediately.

• Directions

  • Wash affected area and dry thoroughlyApply thin layer over affected area twice daily (morning and night)Supervise 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 dailyFor athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksIf conditions persists longer, ask a doctorThis product is not effective on scalp or nails.

• Other Information

  • Store between 15° and 30° C (59° and 86°F)Lot No. & Exp. Date: See box or crimp of tube.

• Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraffin

Other

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujrat. India

* Please review the disclaimer below.