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| Product NDC Code | 69396-143 | ||||
|---|---|---|---|---|---|
| Drug Name | Clotrimazole antifungal |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 309370 | ||||
| Application Number | M005 | ||||
| Labeler Name | Trifecta Pharmaceuticals USA, LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Clotrimazole USP, 1.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Spray over affected area If bandaged, let dry first Not to be used on children under 12 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ethanol, Propylene glycol, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Cures most Athlete's foot (tinea pedis) Jock Itch (Tinea Cruris) Ringwork (Tinea corporis) Effectively relieves Itching Cracking Burning Discomfort that can accompany these conditions
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Clotrimazole Antifungal Clotrimazole PROPYLENE GLYCOL WATER CLOTRIMAZOLE CLOTRIMAZOLE ALCOHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging 4310 GLOBE CLOTRIMAZOLE SOLUTION 1 percent 10ML 110723 CDER FILE
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com Globe® Clotrimazole anti-fungal solution is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®AF.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a Doctor before use Ask a doctor before use on children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Call 1-888-296-9067
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor If irritation occurs If there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid Contact with Eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 15º-30ºC (59º-86ºF)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For External Use Only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API