NDC 76413-351 Clotrimazole
NDC Product 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.
NDC Code Structure
- 76413 - Central Texas Community Health Centers
- 76413-351 - Clotrimazole
NDC 76413-351-30
Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE
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
Dosage Form: -
Product Type: 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.
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 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’.
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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
- Active Ingredient
- Purpose
- Uses
- Warnings
- Otc - Ask Doctor
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
- Questions?
- How Supplied
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.