Label: TERRASIL RAPID-CLEAR ANTI-FUNGAL- clotrimazole kit
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-165-25, 24909-175-25, 24909-185-75 - 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 April 18, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.
Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.
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PRINCIPAL DISPLAY PANEL - BOX
Anti-Fungal
- Cures Most Fungal and Tinea Infections
- Athlete's Foot, Jock Itch and Ringworm
- Irritation, Burning and Discoloration
All Natural
terrasil
RAPID-CLEAR ANTI-FUNGAL OINTMENT
Plus Medicated Cleansing Bar
6X FASTER
compared to leading brands
in scientific studiesTHE END OF SUFFERING SKIN
Healing and Relief Since 2004
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INGREDIENTS AND APPEARANCE
TERRASIL RAPID-CLEAR ANTI-FUNGAL
clotrimazole kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-165 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-165-25 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 25 g Part 2 1 CARTON 75 g Part 1 of 2 TERRASIL RAPID-CLEAR ANTI-FUNGAL
clotrimazole ointmentProduct Information Item Code (Source) NDC:24909-175 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) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PEPPERMINT OIL (UNII: AV092KU4JH) SILVER OXIDE (UNII: 897WUN6G6T) TEA TREE OIL (UNII: VIF565UC2G) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-175-25 25 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/18/2014 Part 2 of 2 TERRASIL ANTI-FUNGAL MEDICATED CLEANSING BAR
clotrimazole soapProduct Information Item Code (Source) NDC:24909-185 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) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) LAURIC ACID (UNII: 1160N9NU9U) LAVENDER OIL (UNII: ZBP1YXW0H8) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) OLIVE OIL (UNII: 6UYK2W1W1E) PALM ACID (UNII: B6G0Y5Z616) PALM KERNEL ACID (UNII: 79P21R4317) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) PEPPERMINT OIL (UNII: AV092KU4JH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILVER OXIDE (UNII: 897WUN6G6T) SODIUM STEARATE (UNII: QU7E2XA9TG) SHEA BUTTER (UNII: K49155WL9Y) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PALMATE (UNII: S0A6004K3Z) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) SORBITOL (UNII: 506T60A25R) TEA TREE OIL (UNII: VIF565UC2G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-185-75 75 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/18/2014 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-165) , label(24909-165)