TERRASIL RINGWORM TREATMENT MAX- 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.

----------

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Cures most ringworm (tinea cruris). For effective relief of itching, redness, irritation and discomfort associated with ringworm.

Warnings

For external use only. Do not use on children under 2 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 ointment 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), bentonite (volcanic clay), cottonseed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, stearic acid, tea tree oil, zinc oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

terrasil MAX with Activated Minerals

Ringworm Treatment

Terrasil

TERRASIL RINGWORM TREATMENT MAX
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SILVER STEARATE (UNII: 4H6PCL92ZN)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-102-14	14 g in 1 JAR; Type 0: Not a Combination Product	05/12/2014	05/21/2018
2	NDC:24909-102-44	44 g in 1 JAR; Type 0: Not a Combination Product	05/12/2014	05/21/2018
3	NDC:24909-102-15	14 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018
4	NDC:24909-102-50	50 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	05/12/2014

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-102)

Revised: 5/2023

Document Id: fb44b8fb-21a3-2dd2-e053-6394a90ac243

Set id: fc2b740a-49c1-4a01-a94c-8cade52a2b82

Version: 3

Effective Time: 20230509

Aidance Skincare & Topical Solutions, LLC