TERRASIL TINEA TREATMENT 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

Clears up tinea fungal infections including tinea versicolor, tinea corporis, tinea cruris and tinea pedis. 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, get medical help or contact a Poison Control Center right away.

Directions

Wash and dry affected skin. Apply ointment over 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), bentonite (volcanic clay)*, cedarwood oil, cottonseed oil*, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver stearate, sunflower oil*, zinc oxide
♦6X the fungal fighting power of other brands - data on file.
*may contain this ingredient.

Questions?

401-432-7750 or learn more at www.aidance.com

Product label

image description

TERRASIL TINEA TREATMENT MAXIMUM STRENGTH 
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-215
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)  
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-215-20200 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2021
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-215)

Revised: 5/2022
Document Id: df62a3f7-1a81-7dff-e053-2995a90af540
Set id: 983678a4-5ac7-4903-9e4b-ac28da857758
Version: 1
Effective Time: 20220519
 
Aidance Skincare & Topical Solutions, LLC