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| Product NDC Code | 71205-438 | ||||
|---|---|---|---|---|---|
| Drug Name | Major 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 | Proficient Rx LP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 • Clean the affected area and dry thoroughly. • Apply a thin layer of this 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 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 conditions 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 aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, 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), 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 Cream
Spl product data elements
Usually a list of ingredients in a drug product.Major Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 BENZYL ALCOHOL SORBITAN MONOSTEARATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF OCTYLDODECANOL CETYL PALMITATE
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 – ½ oz. Tube NDC 71205-438-05 CLOTRIMAZOLE ANTI-FUNGAL CREAM CREAM USP, 1% Cures Most Athlete's Foot NET WT. 14.17 g (1/2oz) 71205-438-05
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
Other information • Store at controlled room temperature 15°-30°C (59°-86°F). • Close cap tightly after use.
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. • For external use only. • Avoid contact with eyes. • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult 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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance 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? Adverse Drug Event call (800)616-2471 Dist. By MAJOR PHARMACEUTICALS 31778 Enterprise Drive, Livonia, Ml 48150 USA Relabeled By Proficient Rx LP Thousand Oaks, CA 91320 Re-Oder No. 100431
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 • Do not use on children under 2 years of age unless directed by a doctor. • For external use only. • Avoid contact with eyes. • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor. • Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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