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| Product NDC Code | 83324-041 | ||||
|---|---|---|---|---|---|
| Drug Name | Clotrimazole 1% |
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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 | Chain Drug Marketing Association Inc. | ||||
| 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 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 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 Dimethyl Sulfoxide, Ethylparaben, Glycerol, Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Edetate disodium, 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), 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.Clotrimazole 1% Clotrimazole BUTYLATED HYDROXYTOLUENE CETOSTEARYL ALCOHOL GLYCERYL MONO- AND DICAPRYLATE MINERAL OIL ALCOHOL DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN LAURETH-23 PETROLATUM WATER CLOTRIMAZOLE CLOTRIMAZOLE EDETATE DISODIUM
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.Packaging 99261 QC CLOTRIMAZOLE CREAM 1 PERCENT 1OZ REV10 050624 CDER
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.In case of accidental ingestion, seek professional assistance or contact a Poison Control 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 or Comments? DISTRIBUTED BY: CDMA Inc. Novi, MI. 48375 www.qualitychoice.com This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF
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 a Doctor if: On children under 2 years of age unless directed by doctor.
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 ● Do not use on children under 2 years of age unless directed by a doctor. ● When using this product avoid contact with eyes.
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