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| Product NDC Code | 36800-508 | ||||
|---|---|---|---|---|---|
| Drug Name | Clotrimazole |
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| Type | Generic | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | VAGINAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part333C | ||||
| Labeler Name | TOP CARE (Topco Associates LLC) | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients 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 wash 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, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition lasts longer, contact a doctor this product is not effective on the scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
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 treats most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling, and discomfort
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 Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETYL ESTERS WAX OCTYLDODECANOL POLYSORBATE 60 WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SORBITAN MONOSTEARATE
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.Principal display panel COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT* Athlete's Foot Cream Cure Most Athlete's Foot RELIEVES: Itching Burning Cracking Scaling Proven Clinically Effective in the Treatment of Most Athlete's Foot Soothes Itching and Burning NET WT. OZ (g) *This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 www.topcarebrand.com
Package label TOPCARE HEALTH Athlete's Foot Cream Clotrimazole, USP 1%
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children under 2 years of age, unless directed by a doctor.
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature 20º-25ºC (68º-77ºF) before using any medication, read all label directions. Keep carton, it contains important information.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question or comments? Call toll free 1-888-423-0139
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 Do not use on children under 2 years of age, unless directed by a doctor. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foots and ringworm) or within 2 weeks (for jock itch) Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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