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| Product NDC Code | 24909-038 | ||||
|---|---|---|---|---|---|
| Drug Name | Terrasil the fungal solution kit |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 251267, 418475 |
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| Application Number | M005 | ||||
| Labeler Name | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Clotrimazole 1% Antifungal
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 Ointment : Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product. Cleaning Bar : Wash affected area daily. For best results use with terrasil® Antifungal ointment products.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ointment : beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide Cleansing Bar : beeswax (organic), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, olive oil, pentasodium pentetate, peppermint oil, shea butter (butyrospermum), silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, titanium dioxide, 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 Ointment : Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions. Cleansing Bar : For relief of most fungal skin infection symptoms.
Spl product data elements
Usually a list of ingredients in a drug product.terrasil The Fungal Solution Kit CLOTRIMAZOLE Terrasil Anti-Fungal Treatment MAX CLOTRIMAZOLE YELLOW WAX COCONUT OIL COTTONSEED OIL JOJOBA OIL MAGNESIUM OXIDE PALM OIL PEPPERMINT OIL SAGE OIL SILVER STEARATE TEA TREE OIL WITCH HAZEL ZINC OXIDE CLOTRIMAZOLE CLOTRIMAZOLE terrasil Antifungal Cleansing Bar CLOTRIMAZOLE YELLOW WAX COCONUT OIL JOJOBA OIL GLYCERIN LAURIC ACID LAVENDER OIL MAGNESIUM OXIDE OLIVE OIL PENTASODIUM PENTETATE PEPPERMINT OIL SHEA BUTTER SODIUM CHLORIDE SODIUM CITRATE SODIUM LAURATE SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM MYRISTATE SODIUM OLEATE SODIUM OLIVATE SODIUM STEARATE SORBITOL TEA TREE OIL ETIDRONATE TETRASODIUM TITANIUM DIOXIDE WATER ZINC OXIDE SILVER STEARATE 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.Product label image description
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.Other information Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.
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 two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician. 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