TERRASIL THE FUNGAL SOLUTION KIT- clotrimazole 
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions

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Drug Facts

Active Ingredient                                  Purpose

Clotrimazole 1%                                Antifungal

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.

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

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)

Revised: 11/2023
Document Id: 09aa1e48-454d-491b-e063-6394a90ab19a
Set id: 9a5eb581-62a2-41fe-a174-e852fc47e235
Version: 1
Effective Time: 20231108
 
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions