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| Product NDC Code | 59088-441 | ||||
|---|---|---|---|---|---|
| Drug Name | Mycozyl ac |
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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 | PureTek Corporation | ||||
| 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.Directions ■ Clean the affected area and dry thoroughly. ■ Apply a thin layer of the product over the 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. Use under the direction of a medical practitioner
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Purified Water), Beta-Glucan, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glycine Soja (Soybean) Oil, 1,2-Hexanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Panthenol, PEG-100 Stearate, PEG-40 Stearate PEG-8, Polysorbate 60, Propylene Glycol, Sholigopeptide-1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, DL-alpha-tocopheryl acetate
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 ■ For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). ■ Relieves itching, burning, cracking, scaling, and discomfort which accompanies these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Mycozyl AC Clotrimazole DIMETHICONE TEA TREE OIL NEPIDERMIN SODIUM HYDROXIDE POLYETHYLENE GLYCOL 400 SOYBEAN OIL PANTHENOL CURDLAN SHEA BUTTER CAPRYLYL GLYCOL EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE, DL- ALCOHOL GLYCERIN GLYCERYL CAPRYLATE GLYCERYL MONOSTEARATE 1,2-HEXANEDIOL PEG-100 STEARATE PROPYLENE GLYCOL JOJOBA OIL PEG-40 STEARATE CETOSTEARYL ALCOHOL POLYSORBATE 60 WATER 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.Mycozyl AC TM Manufactured in the USA by: PureTek Corporation San Fernando, CA 91340 For questions or information call toll-free: 1-877-921-7873 label
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 Active ingredient Clotrimazole 1% Purpose Antifungal
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.
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.Do not use ■ on children under 2 years of age unless directed by a doctor ■ for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor ■ for jock itch - if irritation occurs or if there is no improvement in 2 weeks, discontinue use and consult a doctor
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 avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ Store at 15° - 30°C (59° - 86°F) ■ avoid excessive heat ■ do not use if package is damaged
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. When using this product avoid contact with eyes Do not use ■ on children under 2 years of age unless directed by a doctor ■ for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor ■ for jock itch - if irritation occurs or if there is no improvement in 2 weeks, discontinue use and consult a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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