Label: VITILIGO- echinacea, iris versicolor, rumex crispus, berberis vulgaris, bovista, dolichos pruriens, hura brasiliensis, hydrocotyle asiatica, lycopodium clavatum, mezereum, rhus toxicodendron, sepia, taraxacum officinale, thuja occidentalis, urtica urens, arsenicum album liquid

  • NDC Code(s): 55714-2592-1
  • Packager: Newton Laboratories, Inc.
  • 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 11, 2024

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  • INDICATIONS & USAGE SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Iris versicolor 6x, Rumex crispus 6x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Dolichos 15x, Echinacea 15x, Hura bras. 15x, Hydrocotyle 15x, Lycopodium 15x, Mezereum 15x, Rhus tox 15x, Rumex crisp. 15x, Sepia 15x, Taraxacum 15x, Thuja occ. 15x, Urtica ur. 15x.

  • OTC - PURPOSE SECTION

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

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

  • QUESTIONS SECTION

    newtonlabs.net – Questions? 800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.

  • WARNINGS SECTION

    WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    VITILIGO 
    echinacea, iris versicolor, rumex crispus, berberis vulgaris, bovista, dolichos pruriens, hura brasiliensis, hydrocotyle asiatica, lycopodium clavatum, mezereum, rhus toxicodendron, sepia, taraxacum officinale, thuja occidentalis, urtica urens, arsenicum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2592
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED15 [hp_X]  in 1 mL
    HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP15 [hp_X]  in 1 mL
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA15 [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
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT15 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE15 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]  in 1 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS15 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK15 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 1 mL
    LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY15 [hp_X]  in 1 mL
    MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2592-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/11/2024
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2592)
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