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| Product NDC Code | 70000-0667 | ||||||
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| 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 | ||||||
| RxCUI drug identifier | 309367 | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Cardinal Health 110 dba LEADER | ||||||
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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 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 oover 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 Dimethyl Sulfoxide, Ethylparaben, Glycerol, Polyoxyethylene lauryl ether, Mineral Oil, Petrolatum, Water, alcohol, Mono and di-glycerides, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.
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, burning, cracking, scaling and discomfort which 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.Clotrimazole Clotrimazole MINERAL OIL DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN LAURETH-23 PETROLATUM WATER EDETATE DISODIUM GLYCERYL MONO AND DIPALMITOSTEARATE BUTYLATED HYDROXYTOLUENE ALCOHOL CETOSTEARYL ALCOHOL 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.Label 5888649 Leader Clotrimazole Cream 1 percent 1oz rev1_24 042924 CDER
5888656 Leader Clotrimazole Cream 1 percent 9.5oz Rev1_24 042924 CDER
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 Do not use on children under 2 years of age unless direcgted 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 this and all drugs out of the reach of children 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 (1-800-222-1222) 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? Adverse drug event call 1-888-296-9067 Distributed by Cardinal Health Dublin, Ohio 43017 www.myleader.com 1-800-200-6313 * This product is not manufactured or distributed by Schering-Plough, Inc., the distributor of Lotrimin®AF. ©2024 Cardinal Health. All rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. CIN 5888649
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if irritaion occurs There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product When using this product avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at controlled room temperature 15°-30°C (59°- 86°F) Close cap tightly after use.
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.
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