TERRASIL RAPID-CLEAR ANTI-FUNGAL- clotrimazole kit

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.

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, call poison control or seek medical help.

Directions

Ointment: Wash and dry affected skin.
Apply a thin layer of Terrasil 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.
Cleansing Bar: Wash affected area daily.

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

PRINCIPAL DISPLAY PANEL - BOX

Anti-Fungal

• Cures Most Fungal and Tinea Infections
• Athlete's Foot, Jock Itch and Ringworm
• Irritation, Burning and Discoloration

All Natural

terrasil

RAPID-CLEAR ANTI-FUNGAL OINTMENT

Plus Medicated Cleansing Bar

6X FASTER

compared to leading brands
in scientific studies

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

INGREDIENTS AND APPEARANCE

TERRASIL RAPID-CLEAR ANTI-FUNGAL 
clotrimazole kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-165

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-165-25	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	25 g
Part 2	1 CARTON	75 g

Part 1 of 2

TERRASIL RAPID-CLEAR ANTI-FUNGAL 
clotrimazole ointment

Product Information
Item Code (Source)	NDC: 24909-175
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
BENTONITE (UNII: A3N5ZCN45C)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
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: 24909-175-25	25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/18/2014

Part 2 of 2

TERRASIL ANTI-FUNGAL MEDICATED CLEANSING BAR 
clotrimazole soap

Product Information
Item Code (Source)	NDC: 24909-185
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
BENTONITE (UNII: A3N5ZCN45C)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
LAURIC ACID (UNII: 1160N9NU9U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
OLIVE OIL (UNII: 6UYK2W1W1E)
PALM ACID (UNII: B6G0Y5Z616)
PALM KERNEL ACID (UNII: 79P21R4317)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILVER OXIDE (UNII: 897WUN6G6T)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SORBITOL (UNII: 506T60A25R)
TEA TREE OIL (UNII: VIF565UC2G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-185-75	75 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/18/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-165) , label(24909-165)