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Product NDC Code | 24909-037 | ||||
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Drug Name | Terrasil antifungal cleansing bar |
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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 | SOAP | ||||
RxCUI drug identifier | 251267 | ||||
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 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 Wash affected area well, rinse after 2 minutes. Dry thoroughly. Use 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 with Terrasil Antifungal Ointment for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients beeswax, citric acid, glycerin, jojoba oil, lavender oil, magnesium oxide, MCT oil, peppermint oil, propylene glycol, silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium shea butterate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, tetrasodium iminodisuccinate, 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 Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris), Ringworm (tinea corporis). Relieves Itching, burning, cracking.
Purpose
Information about the drug product’s indications for use.Pupose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.terrasil Antifungal Cleansing Bar CLOTRIMAZOLE YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL GLYCERIN CITRIC ACID LAVENDER OIL MAGNESIUM OXIDE PROPYLENE GLYCOL 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 TETRASODIUM IMINODISUCCINATE
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.Cleansing Bar Box
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.Questions? 401-432-7750 or www.aidance.com
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.If swallowed, call poison control or seek medical help.
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 doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, or 2 weeks for jock itch, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, call poison control or seek medical help.
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