Terrasil Foot And Nail Anti-Fungal Maximum Strength (Clotrimazole) Ointment [Aidance Skincare & Topical Solutions, Llc] -

TERRASIL FOOT AND NAIL ANTI-FUNGAL MAXIMUM STRENGTH (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC	24909-126-25
Set ID	e63fb1f4-cf30-4d13-b14b-63f7c6a74ba6
Category	HUMAN OTC DRUG LABEL
Packager	Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-126-25	25 g in 1 TUBE; Type 0: Not a Combination Product	06/27/2014

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

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

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

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Medic