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| Product NDC Code | 69740-329 | ||||
|---|---|---|---|---|---|
| Drug Name | Secura antifungal extra thick |
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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 | 998483 | ||||
| Application Number | M005 | ||||
| Labeler Name | Smith & Nephew Medical Ltd | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Miconazole nitrate 2%
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) 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 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.INACTIVIE INGREDIENTS Antifungal Greaseless allantoin, cetearyl alcohol, ceteth-20, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water Antifungal Extra Thick benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, karaya gum, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, zinc oxide
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 Antifungal Extra Thick Cures most jock itch (tinea cruris), ringworm (tinea corporis) and athlete's foot (tinea pedis) Antifungal Greaseless Cures most athlete's foot, jock itch and ringworm
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.Secura Antifungal Greaseless MICONAZOLE NITRATE DIHEPTYL ADIPATE PEG-40 CASTOR OIL OCTYL PALMITATE ANHYDROUS CITRIC ACID OCTYL STEARATE ALLANTOIN DIAZOLIDINYL UREA GLYCERYL MONOSTEARATE METHYLPARABEN ALPHA-TOCOPHEROL ACETATE PETROLATUM PROPYLPARABEN SODIUM CETOSTEARYL SULFATE SODIUM CITRATE WATER CETOSTEARYL ALCOHOL CETETH-20 MICONAZOLE NITRATE MICONAZOLE Secura Antifungal Extra Thick MICONAZOLE NITRATE METHYL GLUCOSE DIOLEATE BENZETHONIUM CHLORIDE BUTYLPARABEN DIAZOLIDINYL UREA KARAYA GUM METHYLPARABEN MINERAL OIL PETROLATUM ZINC OXIDE WATER ALPHA-TOCOPHEROL ACETATE CETOSTEARYL ALCOHOL CARBOXYMETHYLCELLULOSE MICONAZOLE NITRATE MICONAZOLE
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 - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL GREASELESS - TUBE(57g) Item #59432800 NDC 69740-328-00 Antifungal Greaseless 2% Miconazole Nitrate Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis) Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions Pediatric tested CHG compatible Smith & Nephew Secura ◊ Antifungal Greaseless Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN, England Trademark of Smith & Nephew Certain Marks Reg'd U.S. Pat & Tm. Off. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL EXTRA THICK - TUBE(92g) Item #59432900 NDC 69740-329-00 Antifungal Greaseless 2% Miconazole Nitrate Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis) Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions Pediatric tested CHG Compatible Can be used on denuded skin Smith & Nephew Secura ◊ Antifungal Extra Thick Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN England Trademark of Smith & Nephew Certain marks Reg'd U.S. Pat & Tm. Off. 69740-328 secura-antifungal-fig-92g
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 Keep reach out of children. If swallowed, get medical help or contact a Poison Control Center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTION OR COMMENTS? 1 800 876-1261
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store at controlled room temperature 59°F-86°F (15°C-30°C) SECURA ANTIFUNGAL EXTRA THICK /SECURA ANTIFUNGAL GREASELESS Store at controlled room temperature 59 o F-86 o F (15 o C-30 o C)
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 old unless directed by a doctor Avoid contact with the eyes Stop use and ask a doctor if irritation occurs or if there is no improvement Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately
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