FUNGUS FIGHTER - 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 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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INDICATIONS & USAGE SECTION

Fungus Fighter Formulated for symptoms associated with ringworm, athlete's foot and other fungal conditions of the nails, scalp and skin.

DOSAGE & ADMINISTRATION 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Candida albicans 15x, Sanicula 15x,Tellurium metallicum 15x, Torula cerevisiae 15x, Antimon. crud.10x, Arsenicum alb. 10x, Baryta carb. 10x, Bryonia 10x, Calc. carb.10x, Carbo veg. 10x, Cuprum met. 10x, Dulcamara 10x, Graphites 10x, Kali carb. 10x, Lachesis 10x, Lycopodium 10x, Mezereum 10x, Nitricum ac. 10x, Phosphorus 10x, Phytolacca 10x, Sepia 10x, Silicea 10x, Sulphur 10x, Sulphuricum ac. 10x, Zinc. met. 10x, Apis mel. 3x, Phytolacca 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with ringworm, athlete's foot and other fungal conditions of the nails, scalp and skin.

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, 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.

FUNGUS FIGHTER
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., thuja occ. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2226
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Candida Albicans (Candida Albicans)	Candida Albicans	15 [hp_X] in 1 mL
Sanicula Europaea Leaf (Sanicula Europaea Leaf)	Sanicula Europaea Leaf	15 [hp_X] in 1 mL
Tellurium (Tellurium)	Tellurium	15 [hp_X] in 1 mL
Saccharomyces Cerevisiae (Saccharomyces Cerevisiae)	Saccharomyces Cerevisiae	15 [hp_X] in 1 mL
Antimony Trisulfide (Antimony Trisulfide)	Antimony Trisulfide	10 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	10 [hp_X] in 1 mL
Barium Carbonate (Barium Cation)	Barium Carbonate	10 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	10 [hp_X] in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude)	Oyster Shell Calcium Carbonate, Crude	10 [hp_X] in 1 mL
Activated Charcoal (Activated Charcoal)	Activated Charcoal	10 [hp_X] in 1 mL
Copper (Copper)	Copper	10 [hp_X] in 1 mL
Solanum Dulcamara Top (Solanum Dulcamara Top)	Solanum Dulcamara Top	10 [hp_X] in 1 mL
Graphite (Graphite)	Graphite	10 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	10 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	10 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	10 [hp_X] in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark)	Daphne Mezereum Bark	10 [hp_X] in 1 mL
Nitric Acid (Nitric Acid)	Nitric Acid	10 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	10 [hp_X] in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root)	Phytolacca Americana Root	10 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	10 [hp_X] in 1 mL
Silicon Dioxide (Silicon Dioxide)	Silicon Dioxide	10 [hp_X] in 1 mL
Sulfur (Sulfur)	Sulfur	10 [hp_X] in 1 mL
Sulfuric Acid (Sulfuric Acid)	Sulfuric Acid	10 [hp_X] in 1 mL
Zinc (Zinc)	Zinc	10 [hp_X] in 1 mL
Apis Mellifera (Apis Mellifera)	Apis Mellifera	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:55714-2226-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2226-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2226-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2226), API MANUFACTURE(55714-2226)

Revised: 03/2011

Document Id: 6328a89e-af3d-21bf-5df7-89f860360483

Set id: 0c63cb53-613c-e471-a2f6-172036dddb42

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.