NDC 21695-935 Clotrimazole

NDC Product Code 21695-935

NDC CODE: 21695-935

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.

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

  • 21695 - Rebel Distributors Corp.

NDC 21695-935-45

Package Description: 45 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 21695-935 is a product labeled by Rebel Distributors Corp.. The product's dosage form is and is administered via form.

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)
  • OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • 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: Rebel Distributors Corp.
Labeler Code: 21695
Start Marketing Date: 07-16-1993 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: 12-31-2017 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".

* 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

Clotrimazole 50mg

Purpose

Vaginal antifungal/external vulvar antifungal

Keep Out Of Reach Of Children

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

Uses

Treats vaginal yeast (candida) infectionsRelieves external vulvar itching and irritation associated with a yeast infection

Warnings

For vaginal or external vulvar use only.Do not use:° If you have abdominal pain, fever, or a foul smelling vaginal discharge.Contact your doctor immediately.° In children less than 12 years of age.Ask a doctor before use if you have:° vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.° symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection from HIV - the virus that causes AIDS). Please read enclosed educational pamphlet.When using this product do not use tampons.Stop use and ask a doctor if:symptoms do not get better in 3 days or infection isn't gone in 7 days. You may have a condition other than a yeast infection.If pregnant or breast-feeding, ask a health professional before use.

Directions

° before using this product, read the enclosed pamphlet° fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Throw applicator away after use.° for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.

Other Information

° store at room temperature between 2° and 30°C (36° to 86°F)° ° see end flaps of carton and tube for lot number and expiration date° safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.Questions? 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

Inactive Ingredients

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

* Please review the disclaimer below.