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.

  • Active Ingredient                                  Purpose

    Clotrimazole 1%                                Antifungal

  • PURPOSE

  • 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.

  • 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

    Ointment: Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

    Cleaning Bar: Wash affected area daily. For best results use with
    terrasil® Antifungal ointment products.

  • 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

    Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL THE FUNGAL SOLUTION KIT 
    clotrimazole kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-038
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-038-011 in 1 KIT10/02/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 g
    Part 21 BOX 75 g
    Part 1 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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-106-1514 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
    Part 2 of 2
    TERRASIL ANTIFUNGAL CLEANSING BAR 
    clotrimazole soap
    Product Information
    Item Code (Source)NDC:24909-037
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-037-7575 g in 1 BOX; 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 DrugM00510/02/2023
    Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-038, 24909-106, 24909-037)