NDC 76413-351 Clotrimazole

NDC Product Code 76413-351

NDC CODE: 76413-351

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: 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.

Product Characteristics

Color(s):
WHITE (C48325 - SMOOTH)

NDC Code Structure

  • 76413 - Central Texas Community Health Centers

NDC 76413-351-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Clotrimazole with NDC 76413-351 is a product labeled by Central Texas Community Health Centers. The generic name of Clotrimazole is . The product's dosage form is and is administered via form.

Labeler Name: Central Texas Community Health Centers

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)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Product Labeler Information

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

Labeler Name: Central Texas Community Health Centers
Labeler Code: 76413
Start Marketing Date: 06-01-1995 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Clotrimazole

Clotrimazole is pronounced as (kloe trim' a zole)

Why is clotrimazole medication prescribed?
Clotrimazole is used to treat yeast infections of the vagina, mouth, and skin such as athlete's foot, jock itch, and body ringworm. It can also be used to prevent oral th...
[Read More]

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Clotrimazole Product Label Images

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

Other

Drug Facts

Distributed by:Taro PharmaceuticalsU.S.A., Inc.Hawthorne, NY 10532

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)for effective relief ofitchingscalingcrackingburningrednesssorenessirritationdiscomfort

Warnings

For external use only

Otc - Ask Doctor

  • Ask a doctor before useon children under 2 years of age

Otc - When Using

  • When using this productavoid contact with eyes

Otc - Stop Use

  • Stop use and ask a doctor ifirritation occursthere is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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

  • This product is not effective on the scalp or nails.For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.clean 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; change shoes and socks at least once daily

Other Information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.store between 2°- 30°C (36° - 86°F)see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

How Supplied

Product: 76413-351NDC: 76413-351-30 30 g in a TUBE / 1 in a CARTON

* Please review the disclaimer below.