TERRASIL FOOT AND NAIL ANTI-FUNGAL MAXIMUM STRENGTH- clotrimazole ointment 
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.

Directions

Wash and dry affected skin. Apply a thin layer of cream 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.

Inactive Ingredients

beeswax (organic), cotton seed oil, bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Questions?401-432-7750 or www.Aidance.com

PRINCIPAL DISPLAY PANEL - 25g Tube

ALL NATURAL

terrasil

MAX Strength

FOOT & NAIL

ANTI-FUNGAL OINTMENT

with Activated Minerals®

Tube Image

TERRASIL FOOT AND NAIL ANTI-FUNGAL  MAXIMUM STRENGTH
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-126-2525 g in 1 TUBE; Type 0: Not a Combination Product06/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/27/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-126) , label(24909-126)

Revised: 12/2018
Document Id: 77d1a1b1-6e12-4af6-b27d-22f3510360d3
Set id: e63fb1f4-cf30-4d13-b14b-63f7c6a74ba6
Version: 2
Effective Time: 20181229
 
Aidance Skincare & Topical Solutions, LLC