TERRASIL SERIOUS TINEA TREATMENT- clotrimazole, thuja occidentalis 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Terrasil Serious Tinea Treatment

Active Ingredient

Ointment: Clotrimazole 1%

Cleansing Bar: Thuja Occidentalis 6X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Purpose

Antifungal

Uses

Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Cleansing Bar: For most fungal infection.

Warnings

For external use only.
Do not use on 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 4 weeks, discontinue use and consult a physician.

Keep out of reach of children. If swallowed, call poison control or seek medical help.

Directions

Ointment: Wash and dry affected skin. Massage oinment in to affected skin. Reapply up to 4 times daily. Supervise children in the use of this product. Store at room temperature. May stain fabrics.
Cleansing Bar: Wash affected area daily.

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay)*, cedarwood oil, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.

Cleansing Bar: beeswax (organic), bentonite (volcanic clay), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, shea butter, silver oxide, sodium chloride, sodium citrate, sodium hydroxide, sodium laurate, SLES, SLS, sodium olivate, sodium palm kernelate, sodium palmate, sodium stearate, sorbitol, stearic acid, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide.

*may contain this ingredient.

PRINCIPAL DISPLAY PANEL

SERIOUS TINEA TREATMENT
2 PRODUCT SYSTEM

All Natural
terrasil®
1> Anti-Tinea Ointment
2> Anti-Fungal Cleansing Bar

terrasil

TERRASIL SERIOUS TINEA TREATMENT 
clotrimazole, thuja occidentalis kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-170
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-170-251 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package01/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 14 g
Part 21 CARTON 75 g
Part 1 of 2
TERRASIL TINEA TREATMENT 
clotrimazole ointment
Product Information
Item Code (Source)NDC:24909-178
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
BENTONITE (UNII: A3N5ZCN45C)  
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SAGE OIL (UNII: U27K0H1H2O)  
SILVER OXIDE (UNII: 897WUN6G6T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-178-1414 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2017
Part 2 of 2
TERRASIL ANTI-FUNGAL CLEANSING BAR 
thuja occidentalis soap
Product Information
Item Code (Source)NDC:24909-176
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
JOJOBA OIL (UNII: 724GKU717M)  
LAURIC ACID (UNII: 1160N9NU9U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PALM ACID (UNII: B6G0Y5Z616)  
PALM KERNEL ACID (UNII: 79P21R4317)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHEA BUTTER (UNII: K49155WL9Y)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURATE (UNII: K146MR5EXO)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM OLEATE (UNII: 399SL044HN)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-176-7575 g in 1 CARTON; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2017
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-170) , label(24909-170)

Revised: 1/2019
Document Id: b9510f41-fbaf-4cdd-bf5b-ca30f619b9c1
Set id: f69fddf4-b16c-483a-ab07-1c854639612b
Version: 1
Effective Time: 20190104
 
Aidance Skincare & Topical Solutions, LLC