TERRASIL SERIOUS TINEA TREATMENT- clotrimazole, thuja occidentalis kit

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Ointment: Clotrimazole 1%

Cleansing Bar: Thuja Occidentalis 6X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Purpose

Antifungal

Uses

Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Cleansing Bar: For most fungal infection.

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. Massage oinment in to affected skin. Reapply up to 4 times daily. 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)*, cedarwood oil, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.

Cleansing Bar: beeswax (organic), bentonite (volcanic clay), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, shea butter, silver oxide, sodium chloride, sodium citrate, sodium hydroxide, sodium laurate, SLES, SLS, sodium olivate, sodium palm kernelate, sodium palmate, sodium stearate, sorbitol, stearic acid, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide.

*may contain this ingredient.

PRINCIPAL DISPLAY PANEL

SERIOUS TINEA TREATMENT
2 PRODUCT SYSTEM

All Natural
terrasil®
1> Anti-Tinea Ointment
2> Anti-Fungal Cleansing Bar

INGREDIENTS AND APPEARANCE

TERRASIL SERIOUS TINEA TREATMENT 
clotrimazole, thuja occidentalis kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-170

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-170-25	1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package	01/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g
Part 2	1 CARTON	75 g

Part 1 of 2

TERRASIL TINEA TREATMENT 
clotrimazole ointment

Product Information
Item Code (Source)	NDC: 24909-178
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)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
COTTONSEED OIL (UNII: H3E878020N)
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: 24909-178-14	14 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2017

Part 2 of 2

TERRASIL ANTI-FUNGAL CLEANSING BAR 
thuja occidentalis soap

Product Information
Item Code (Source)	NDC: 24909-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	6 [hp_X]  in 1 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)
PALM ACID (UNII: B6G0Y5Z616)
PALM KERNEL ACID (UNII: 79P21R4317)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SILVER OXIDE (UNII: 897WUN6G6T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURATE (UNII: K146MR5EXO)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM OLEATE (UNII: 399SL044HN)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-176-75	75 g in 1 CARTON; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-170) , label(24909-170)