FUNGAL INFECTION - candida albicans, sanicula europaea leaf, tellurium, saccharomyces cerevisiae, antimony trisulfide, arsenic trioxide, barium carbonate, bryonia alba root, oyster shell calcium carbonate, crude, activated charcoal, copper, solanum dulcamara top, graphite, potassium carbonate, lachesis muta venom, lycopodium clavatum spore, daphne mezereum bark, nitric acid, phosphorus, phytolacca americana root, sepia officinalis juice, silicon dioxide, sulfur, sulfuric acid, zinc, apis mellifera, phytolacca americana root, thuja occidentalis leafy twig, apis mellifera, phytolacca americana root and thuja occidentalis leafy twig liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT NAME & INDICATIONS SECTION

FUNGAL INFECTION Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Candida albicans 20x, Sanicula 20x, Tellurium metallicum 20x, Torula cerevisiae 20x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phosphorus 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Apis mel. 8x, Phytolacca 8x, Thuja 8x, Apis mel. 3x, Phytolacca 3x, Thuja 3x.

PURPOSE SECTION

Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 -Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

FUNGAL INFECTION
candida albicans, sanicula, tellurium metallicum, torula cerevisiae, antimon. crud., arsenicum alb., baryta carb., bryonia, calc. carb., carbo veg., cuprum met., dulcamara, graphites, kali carb., lachesis, lycopodium, mezereum, nitricum ac., phosphorus, phytolacca, sepia, silicea, sulphur, sulphuricum ac., zinc. met., apis mel., phytolacca, thuja. liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4618
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Candida Albicans (Candida Albicans)	Candida Albicans	20 [hp_X] in 1 mL
Sanicula Europaea Leaf (Sanicula Europaea Leaf)	Sanicula Europaea Leaf	20 [hp_X] in 1 mL
Tellurium (Tellurium)	Tellurium	20 [hp_X] in 1 mL
Saccharomyces Cerevisiae (Saccharomyces Cerevisiae)	Saccharomyces Cerevisiae	20 [hp_X] in 1 mL
Antimony Trisulfide (Antimony Cation (3+))	Antimony Trisulfide	15 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Barium Carbonate (Barium Cation)	Barium Carbonate	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude)	Oyster Shell Calcium Carbonate, Crude	15 [hp_X] in 1 mL
Activated Charcoal (Activated Charcoal)	Activated Charcoal	15 [hp_X] in 1 mL
Copper (Copper)	Copper	15 [hp_X] in 1 mL
Solanum Dulcamara Top (Solanum Dulcamara Top)	Solanum Dulcamara Top	15 [hp_X] in 1 mL
Graphite (Graphite)	Graphite	15 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	15 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark)	Daphne Mezereum Bark	15 [hp_X] in 1 mL
Nitric Acid (Nitric Acid)	Nitric Acid	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root)	Phytolacca Americana Root	15 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	15 [hp_X] in 1 mL
Silicon Dioxide (Silicon Dioxide)	Silicon Dioxide	15 [hp_X] in 1 mL
Sulfur (Sulfur)	Sulfur	15 [hp_X] in 1 mL
Sulfuric Acid (Sulfuric Acid)	Sulfuric Acid	15 [hp_X] in 1 mL
Zinc (Zinc)	Zinc	15 [hp_X] in 1 mL
Apis Mellifera (Apis Mellifera)	Apis Mellifera	8 [hp_X] in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root)	Phytolacca Americana Root	8 [hp_X] in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig)	Thuja Occidentalis Leafy Twig	8 [hp_X] in 1 mL
Apis Mellifera (Apis Mellifera)	Apis Mellifera	3 [hp_X] in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root)	Phytolacca Americana Root	3 [hp_X] in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig)	Thuja Occidentalis Leafy Twig	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-4618-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-4618-2	59.14 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4618), API MANUFACTURE(55714-4618)

Revised: 06/2011

Document Id: 81a16526-da6e-acc7-53a9-11cad89d5a44

Set id: 931030b4-47e0-db78-37d5-445d88613ca1

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.