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| Product NDC Code | 83474-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Clotrimazole (topical solution), 1% |
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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 | Puro Pharma Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Clotrimazole USP, 1%
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 • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. 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 thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product. For athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes; change shoes and socks at least once daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient polyethylene glycol
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) • Ringworm (tinea corporis) Effectively relieves • itching • cracking • burning • discomfort which 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 (Topical Solution), 1% Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE POLYETHYLENE GLYCOL, UNSPECIFIED
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 Clotrimazole-003
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.Drug Facts
Compare to the active ingredient in Lotrimin ® AF* • Greaseless, Nonstaining Not for Ophthalmic use. Keep this and all medications out of the reach of children. TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase. *All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin ® AF. Keep this carton for important information. Distributed by: Puro Pharma Inc. Poughkeepsie, NY 12601
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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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-(845) 450-0141 Mon-Fri 9:00AM to 5:00PM EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • store between 15°-30°C (59°-86°F)
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. Ask a doctor before use • on children under 2 years of age When using this product • avoid contact with eyes Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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