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| Product NDC Code | 84387-004 | ||||
|---|---|---|---|---|---|
| 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 | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M005 | ||||
| Labeler Name | ALLIED TRADE LINK LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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.DOSAGE AND ADMISITRATION Clotrimazole 1% .. Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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.Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum
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.For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet
Purpose
Information about the drug product’s indications for use.Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.CLOTRIMAZOLE CLOTRIMAZOLE METHYLPARABEN CLOTRIMAZOLE CLOTRIMAZOLE PROPYLENE GLYCOL WHITE PETROLATUM PROPYLPARABEN MINERAL OIL WATER CETOSTEARYL 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.clotrimazole
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.
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.For External Use Only Do not use On children under 2 years of age unless directed by a doctor For diaper rash. When using this product Avoid contact with the eyes Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no improvement within 4 weeks when used for athlete’s foot or ringworm
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