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Product NDC Code | 66977-023 | ||||
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Drug Name | Anti-fungal |
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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 | MPM Medical, LLC | ||||
Packages |
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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.Directions Clean the affected area and dry thoroughly. Apply a thin layer of the 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 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.Inactive Ingredients Alkyl acrylate, Capric triglyceride, Cetearyl alcohol, Diazolidinyl urea, Hydroxyethylcellulose, Methylparaben, Propylparaben, Retinyl palmitate, Silica, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolmine, 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.Use For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis). For relief of itching, scaling, burning and discomfort that accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Anti-Fungal
Spl product data elements
Usually a list of ingredients in a drug product.Anti-Fungal clotrimazole CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE CETOSTEARYL ALCOHOL DIAZOLIDINYL UREA HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) METHYLPARABEN PROPYLPARABEN VITAMIN A PALMITATE SILICON DIOXIDE TETRASODIUM EDETATE DIHYDRATE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER CLOTRIMAZOLE CLOTRIMAZOLE POLYSORBATE 60
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.Package Label MP00023 MPM Anti-Fungal Cream 4 oz
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
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 exteranl use only. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor. Keep out of reach of children
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