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Fungal Infection

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Fungal Infection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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.   

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.       

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., 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 20 [hp_X]
Sanicula Europaea Leaf Sanicula Europaea Leaf 20 [hp_X]
Tellurium Tellurium 20 [hp_X]
SACCHAROMYCES CEREVISIAE 20 [hp_X]
Antimony Trisulfide Antimony Trisulfide 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
BARIUM CARBONATE BARIUM CATION 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X]
Activated Charcoal ACTIVATED CHARCOAL 15 [hp_X]
Copper COPPER 15 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 15 [hp_X]
Graphite GRAPHITE 15 [hp_X]
POTASSIUM CARBONATE CARBONATE ION 15 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 15 [hp_X]
NITRIC ACID NITRIC ACID 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT 15 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 15 [hp_X]
SILICON DIOXIDE 15 [hp_X]
SULFUR SULFUR 15 [hp_X]
SULFURIC ACID SULFURIC ACID 15 [hp_X]
Zinc ZINC 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 8 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 8 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4618-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-4618-2 59.14 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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