Vitiligo

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:42:33

Label at a glance#

ProductVitiligo
Active ingredientIRIS VERSICOLOR ROOT, LYCOPERDON UTRIFORME FRUITING BODY, MUCUNA PRURIENS FRUIT TRICHOME, ECHINACEA, UNSPECIFIED, HURA CREPITANS SAP, CENTELLA ASIATICA, LYCOPODIUM CLAVATUM SPORE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS LEAF, RUMEX CRISPUS ROOT, SEPIA OFFICINALIS JUICE, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS LEAFY TWIG, URTICA URENS, ARSENIC TRIOXIDE, BERBERIS VULGARIS ROOT BARK
Label structure10 sections

Label contents#

Full prescribing information#

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, Berberis vulgaris 10x, Bovista 10x, Dolichos pruriens 10x, Echinacea 10x, Hura brasiliensis 10x, Hydrocotyle asiatica 10x, Lycopodium clavatum 10x, Mezereum 10x, Rhus toxicodendron 10x, Rumex crispus 10x, Sepia 10x, Taraxacum officinale 10x, Thuja occidentalis 10x, Urtica urens 10x, Arsenicum album 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

OTC - 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.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-254055714-2540-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
254018c8-fbd6-4825-e063-6394a90a02be9d3bb3f0-b923-a1d2-e053-2995a90a09022024-10-24WarningsExact identifier
spl set id: 9d3bb3f0-b923-a1d2-e053-2995a90a0902

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.