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

If you are a consumer or patient please visit this version.

  • Active ingredients

    Ointment: Clotrimazole 1%

    Soap Bar: Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris),
    Ringworm (tinea corporis). Relieves Itching, burning, cracking.

  • 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, get medical help or contact a Poison Control Center right away.

  • 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.

  • 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

  • SPL UNCLASSIFIED SECTION

    Retain Carton for Product Information

    Questions? 401-432-7750 or www.aidance.com

  • PRINCIPAL DISPLAY PANEL

    Kit Box

  • INGREDIENTS AND APPEARANCE
    TERRASIL FUNGAL TREATMENT 
    clotrimazole kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-046
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-046-011 in 1 KIT01/01/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE 75 g
    Part 21 TUBE 28 g
    Part 1 of 2
    TERRASIL ANTIFUNGAL BAR 
    clotrimazole soap
    Product Information
    Item Code (Source)NDC:24909-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-047-7575 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM005
    Part 2 of 2
    TERRASIL ANTI-FUNGAL TREATMENT  MAX
    clotrimazole ointment
    Product Information
    Item Code (Source)NDC:24909-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-106-2828 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2025
    Labeler - Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-046) , label(24909-046)