VITILIGO - arsenicum alb., berber. vulg., bovista, dolichos, echinacea, hura brasiliensis, hydrocotyle, lycopodium, mezereum, rhus toxicodendron, rumex crisp., sepia, taraxacum,thuja occ., urtica ur., iris versicolor 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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 Vitiligo

INDICATIONS & USAGE SECTION

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Berber. vulg. 10x, Bovista 10x, Dolichos 10x, Echinacea 10x, Hura brasiliensis 10x, Hydrocotyle 10x, Lycopodium 10x, Mezereum 10x, Rhus toxicodendron 10x, Rumex crisp. 10x, Sepia 10x, Taraxacum 10x, Thuja occ. 10x, Urtica ur. 10x, Echinacea 3x, Iris versicolor 3x, Rumex crisp. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

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

package label

VITILIGO  
arsenicum alb., berber. vulg., bovista, dolichos, echinacea, hura brasiliensis, hydrocotyle, lycopodium, mezereum, rhus toxicodendron, rumex crisp., sepia, taraxacum,thuja occ., urtica ur., iris versicolor liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark10 [hp_X]  in 1 mL
Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A) Giant Puffball10 [hp_X]  in 1 mL
Mucuna Pruriens Fruit Trichome (UNII: 3E271BSI0C) (Mucuna Pruriens Fruit Trichome - UNII:3E271BSI0C) Mucuna Pruriens Fruit Trichome10 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified10 [hp_X]  in 1 mL
Hura Crepitans Sap (UNII: 8UHN1I06UP) (Hura Crepitans Sap - UNII:8UHN1I06UP) Hura Crepitans Sap10 [hp_X]  in 1 mL
Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root10 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice10 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale10 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig10 [hp_X]  in 1 mL
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens10 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2350-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2350-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2350-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2350)

Revised: 3/2011
Document Id: 39a94f92-80ab-2615-2dd5-a93cad659620
Set id: cba959cf-fcc0-ed50-5703-362188d57092
Version: 2
Effective Time: 20110301
 
Newton Laboratories, Inc.