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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated March 1, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!