Label: TERRASIL THE FUNGAL SOLUTION KIT- clotrimazole kit
- NDC Code(s): 24909-037-75, 24909-038-01, 24909-106-15
- Packager: Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
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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.
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Warnings
For external use only.
Do not useon 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. - KEEP OUT OF REACH OF CHILDREN
- Directions
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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
- Other information
- Product label
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INGREDIENTS AND APPEARANCE
TERRASIL THE FUNGAL SOLUTION KIT
clotrimazole kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-038 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-038-01 1 in 1 KIT 10/02/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 14 g Part 2 1 BOX 75 g Part 1 of 2 TERRASIL ANTI-FUNGAL TREATMENT MAX
clotrimazole ointmentProduct Information Item Code (Source) NDC:24909-106 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 YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) COTTONSEED OIL (UNII: H3E878020N) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PALM OIL (UNII: 5QUO05548Z) PEPPERMINT OIL (UNII: AV092KU4JH) SAGE OIL (UNII: U27K0H1H2O) SILVER STEARATE (UNII: 4H6PCL92ZN) TEA TREE OIL (UNII: VIF565UC2G) WITCH HAZEL (UNII: 101I4J0U34) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-106-15 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 Part 2 of 2 TERRASIL ANTIFUNGAL CLEANSING BAR
clotrimazole soapProduct Information Item Code (Source) NDC:24909-037 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 YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) GLYCERIN (UNII: PDC6A3C0OX) LAURIC ACID (UNII: 1160N9NU9U) LAVENDER OIL (UNII: ZBP1YXW0H8) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) OLIVE OIL (UNII: 6UYK2W1W1E) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURATE (UNII: K146MR5EXO) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM MYRISTATE (UNII: 06BLC4V0IV) SODIUM OLEATE (UNII: 399SL044HN) SODIUM OLIVATE (UNII: ND5Y5M6ZUT) SODIUM STEARATE (UNII: QU7E2XA9TG) SORBITOL (UNII: 506T60A25R) TEA TREE OIL (UNII: VIF565UC2G) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) SILVER STEARATE (UNII: 4H6PCL92ZN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-037-75 75 g in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 10/02/2023 Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611) Establishment Name Address ID/FEI Business Operations Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 018950611 manufacture(24909-038, 24909-106, 24909-037)