Label: TERRASIL FUNGAL TREATMENT- clotrimazole kit
- NDC Code(s): 24909-046-01, 24909-047-75, 24909-106-28
- Packager: Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 26, 2024
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- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
Wash affected area well with soap, rinse area after one to two minutes. Dry thoroughly. Apply a layer of ointment over affected area. 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. For best results use both Terrasil Antifungal Ointment and Soap Bar. Store at room temperature. Ointment may temporarily (washable) discolor skin, nails, and fabrics in sunlight.
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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, vegetable stearic acid (naturally sourced)* witch hazel, zinc oxide
Soap Bar: 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
*may contain this ingredient
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INGREDIENTS AND APPEARANCE
TERRASIL FUNGAL TREATMENT
clotrimazole kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-046 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-046-01 1 in 1 KIT 01/01/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 75 g Part 2 1 TUBE 28 g Part 1 of 2 TERRASIL ANTIFUNGAL BAR
clotrimazole soapProduct Information Item Code (Source) NDC:24909-047 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 SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURATE (UNII: K146MR5EXO) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM MYRISTATE (UNII: 06BLC4V0IV) SODIUM OLEATE (UNII: 399SL044HN) SODIUM OLIVATE (UNII: ND5Y5M6ZUT) SODIUM STEARATE (UNII: QU7E2XA9TG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEPPERMINT OIL (UNII: AV092KU4JH) TEA TREE OIL (UNII: VIF565UC2G) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) SILVER STEARATE (UNII: 4H6PCL92ZN) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SHEA BUTTER (UNII: K49155WL9Y) WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635) YELLOW WAX (UNII: 2ZA36H0S2V) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITOL (UNII: 506T60A25R) JOJOBA OIL (UNII: 724GKU717M) GLYCERIN (UNII: PDC6A3C0OX) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-047-75 75 g in 1 PACKAGE; 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 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 PEPPERMINT OIL (UNII: AV092KU4JH) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PALM OIL (UNII: 5QUO05548Z) COTTONSEED OIL (UNII: H3E878020N) SILVER STEARATE (UNII: 4H6PCL92ZN) COCONUT OIL (UNII: Q9L0O73W7L) STEARIC ACID (UNII: 4ELV7Z65AP) JOJOBA OIL (UNII: 724GKU717M) SAGE OIL (UNII: U27K0H1H2O) WITCH HAZEL (UNII: 101I4J0U34) YELLOW WAX (UNII: 2ZA36H0S2V) ZINC OXIDE (UNII: SOI2LOH54Z) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-106-28 28 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 01/01/2025 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(24909-046) , label(24909-046)