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| Product NDC Code | 68001-475 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antifungal cream |
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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 | BluePoint Laboratories | ||||||
| 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 ingredient Clotrimazole 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.For athletes 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 Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 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.Directions 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.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Uses 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 or itching, burning feet.
Spl product data elements
Usually a list of ingredients in a drug product.Antifungal Cream antifungal PROPYLPARABEN WATER WHITE PETROLATUM POLYOXYL 20 CETOSTEARYL ETHER MINERAL OIL CETOSTEARYL ALCOHOL METHYLPARABEN PROPYLENE GLYCOL 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.Clotrimazole 1% 0.5oz 68001-475-45 0.5 tube 0.5 carton
Principal Display Panel Clotrimazole 1% 1oz 68001-475-47 1 oz carton 1 oz tube
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
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? Contact 1-800-707-4621 Manufactured in India by: Gopaldas Visram & Company Limited, Plot No. A327, T.T.C. Indl. Area, M.I.D.C. Mahape, Navi Mumbai - 400710. Mfg. Lic. No.: KD/739 For BluePoint Laboratories Rev 09/2021
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature Preserve in tight containers See crimp of tube or carton for Lot Number and Expiry Date
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 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