TERRASILMED ANTIFUNGAL- clotrimazole ointment

TerrasilMed ANTIFUNGAL by

Drug Labeling and Warnings

TerrasilMed ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Aidance Skincare & Topical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients                Purpose

Clotrimazole 1.0%              Antifungal

PURPOSE

Uses

Treats most fungal skin infections, including ringworm, athletes foot, jock itch 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, consult a physician.

KEEP OUT OF REACH OF CHILDREN

Directions

Wash and dry affected skin. Apply a thin layer of product 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, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid

Questions?

401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASILMED ANTIFUNGAL 
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-026
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
PETROLATUM (UNII: 4T6H12BN9U)
SILVER STEARATE (UNII: 4H6PCL92ZN)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-026-50	50 g in 1 TUBE; Type 0: Not a Combination Product	05/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/08/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-026)