TERRASIL TINEA TREATMENT MAX- clotrimazole ointment

Terrasil Tinea Treatment by

Drug Labeling and Warnings

Terrasil Tinea Treatment 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 Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Clears up tinea fungal infections including tinea corporis, tinea cruris, tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness an 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 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), cottonseed oil, bentonite (volcanic clay), cedarwood oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, stearic acid, zinc oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

All Natural

terrasil®
TINEA TREATMENT
MAXIMUM STRENGTH
with Activated Minerals®

INGREDIENTS AND APPEARANCE

TERRASIL TINEA TREATMENT  MAX
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-104
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)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-104-14	14 g in 1 JAR; Type 0: Not a Combination Product	05/12/2014
2	NDC: 24909-104-44	44 g in 1 JAR; Type 0: Not a Combination Product	05/12/2014
3	NDC: 24909-104-15	14 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018
4	NDC: 24909-104-50	50 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-104) , label(24909-104)