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 
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.

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Fungal Infection

INDICATIONS & USAGE SECTION

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

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.           

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

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4618
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Candida Albicans (UNII: 4D7G21HDBC) (Candida Albicans - UNII:4D7G21HDBC) Candida Albicans20 [hp_X]  in 1 mL
Sanicula Europaea Leaf (UNII: JYZ6110L9I) (Sanicula Europaea Leaf - UNII:JYZ6110L9I) Sanicula Europaea Leaf20 [hp_X]  in 1 mL
Tellurium (UNII: NQA0O090ZJ) (Tellurium - UNII:NQA0O090ZJ) Tellurium20 [hp_X]  in 1 mL
Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae20 [hp_X]  in 1 mL
Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
Barium Carbonate (UNII: 6P669D8HQ8) (Barium Cation - UNII:V645272HLN) Barium Carbonate15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I) Oyster Shell Calcium Carbonate, Crude15 [hp_X]  in 1 mL
Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal15 [hp_X]  in 1 mL
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper15 [hp_X]  in 1 mL
Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top15 [hp_X]  in 1 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mL
Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate15 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Nitric Acid (UNII: 411VRN1TV4) (Nitric Acid - UNII:411VRN1TV4) Nitric Acid15 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root15 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide15 [hp_X]  in 1 mL
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur15 [hp_X]  in 1 mL
Sulfuric Acid (UNII: O40UQP6WCF) (Sulfuric Acid - UNII:O40UQP6WCF) Sulfuric Acid15 [hp_X]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 mL
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera8 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4618-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4618-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4618)

Revised: 6/2011
Document Id: f3047949-5e7a-5237-b6fa-2255dd2f681a
Set id: 931030b4-47e0-db78-37d5-445d88613ca1
Version: 2
Effective Time: 20110601
 
Newton Laboratories, Inc.