TERRASIL RAPID-CLEAR ANTI-FUNGAL- clotrimazole 
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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Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Cures most fungal skin infections, including ringworm and tinea.
For effective relief of itching, scaling, cracking, burning, discoloration, soreness,
irritation, discomfort, redness and chafing associated with fungal skin infections.

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.
Apply a thin layer of Terrasil over the affected area twice daily
(morning and night) or as directed by a doctor. 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), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

PRINCIPAL DISPLAY PANEL - BOX

Anti-Fungal

All Natural

terrasil

RAPID-CLEAR ANTI-FUNGAL OINTMENT

Plus Medicated Cleansing Bar

6X FASTER

compared to leading brands
in scientific studies

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Box

TERRASIL RAPID-CLEAR ANTI-FUNGAL 
clotrimazole kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-165
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-165-251 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 25 g
Part 21 CARTON 75 g
Part 1 of 2
TERRASIL RAPID-CLEAR ANTI-FUNGAL 
clotrimazole ointment
Product Information
Item Code (Source)NDC:24909-175
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)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-175-2525 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/18/2014
Part 2 of 2
TERRASIL ANTI-FUNGAL MEDICATED CLEANSING BAR 
clotrimazole soap
Product Information
Item Code (Source)NDC:24909-185
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)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
JOJOBA OIL (UNII: 724GKU717M)  
LAURIC ACID (UNII: 1160N9NU9U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PALM ACID (UNII: B6G0Y5Z616)  
PALM KERNEL ACID (UNII: 79P21R4317)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SHEA BUTTER (UNII: K49155WL9Y)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
SORBITOL (UNII: 506T60A25R)  
TEA TREE OIL (UNII: VIF565UC2G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-185-7575 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/18/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-165) , label(24909-165)

Revised: 4/2014
Document Id: 9a69f530-dfef-4d2b-888f-5d645c62ae18
Set id: 4cdfaaf0-a764-4393-b9c3-99b0d065eda7
Version: 1
Effective Time: 20140418
 
Aidance Skincare & Topical Solutions, LLC