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| Product NDC Code | 83035-1062 | ||||
|---|---|---|---|---|---|
| Drug Name | Tm-clotrimazole |
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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 | CREAM | ||||
| RxCUI drug identifier | 309367 | ||||
| Application Number | M005 | ||||
| Labeler Name | Singular Dreamer, Ltd dba True Marker | ||||
| 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 ingredients Clotrimazole USP 1% w/w
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 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 the 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 persists longer, consult 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 Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, 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 athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and 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.TM-Clotrimazole Clotrimazole 1% BUTYLATED HYDROXYTOLUENE ALCOHOL CETOSTEARYL ALCOHOL DIMETHYL SULFOXIDE EDETATE DISODIUM ETHYLPARABEN GLYCERIN MINERAL OIL GLYCERYL MONO AND DIPALMITOSTEARATE PETROLATUM GLYCERETH-31 WATER CLOTRIMAZOLE CLOTRIMAZOLE
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.Product label image description
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.Other information Store at controlled room temperature 15° - 30°C (59° - 86°F) Close cap tightly after use.
Questions? 304-742-2433
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 eyes. Stop use and ask a doctor if ● Irritation occurs ● There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). Keep out of reach of children. In case of accidental ingestion, seek professional assistance 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