TERRASIL FUNGAL TREATMENT- clotrimazole kit

terrasil Fungal Treatment by

Drug Labeling and Warnings

terrasil Fungal Treatment by is a Otc medication manufactured, distributed, or labeled by Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TERRASIL FUNGAL TREATMENT 
clotrimazole kit

Product 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 soap

Product 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 ointment

Product 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)