Label: TERRASIL SERIOUS TINEA TREATMENT- clotrimazole, thuja occidentalis kit
- NDC Code(s): 24909-170-25, 24909-176-75, 24909-178-14
- Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 4, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
Cleansing Bar: For most fungal infection.
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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 4 weeks, discontinue use and consult a physician.Keep out of reach of children. If swallowed, call poison control or seek medical help.
- Directions
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Inactive Ingredients
Ointment: beeswax (organic), bentonite (volcanic clay)*, cedarwood oil, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.
Cleansing Bar: beeswax (organic), bentonite (volcanic clay), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, shea butter, silver oxide, sodium chloride, sodium citrate, sodium hydroxide, sodium laurate, SLES, SLS, sodium olivate, sodium palm kernelate, sodium palmate, sodium stearate, sorbitol, stearic acid, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide.
*may contain this ingredient.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TERRASIL SERIOUS TINEA TREATMENT
clotrimazole, thuja occidentalis kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-170 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-170-25 1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package 01/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 14 g Part 2 1 CARTON 75 g Part 1 of 2 TERRASIL TINEA TREATMENT
clotrimazole ointmentProduct Information Item Code (Source) NDC:24909-178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) COTTONSEED OIL (UNII: H3E878020N) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PEPPERMINT OIL (UNII: AV092KU4JH) SAGE OIL (UNII: U27K0H1H2O) SILVER OXIDE (UNII: 897WUN6G6T) STEARIC ACID (UNII: 4ELV7Z65AP) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-178-14 14 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2017 Part 2 of 2 TERRASIL ANTI-FUNGAL CLEANSING BAR
thuja occidentalis soapProduct Information Item Code (Source) NDC:24909-176 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) LAURIC ACID (UNII: 1160N9NU9U) LAVENDER OIL (UNII: ZBP1YXW0H8) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PALM ACID (UNII: B6G0Y5Z616) PALM KERNEL ACID (UNII: 79P21R4317) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) PEPPERMINT OIL (UNII: AV092KU4JH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SILVER OXIDE (UNII: 897WUN6G6T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURATE (UNII: K146MR5EXO) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM OLEATE (UNII: 399SL044HN) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) SODIUM PALMATE (UNII: S0A6004K3Z) SODIUM STEARATE (UNII: QU7E2XA9TG) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-176-75 75 g in 1 CARTON; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2017 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-170) , label(24909-170)
