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

Drug Labeling and Warnings

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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

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®

INGREDIENTS AND APPEARANCE

TERRASIL FOOT AND NAIL ANTI-FUNGAL  MAXIMUM STRENGTH
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-126-25	25 g in 1 TUBE; Type 0: Not a Combination Product	06/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/27/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-126) , label(24909-126)