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#
Contacts and useful links#
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
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
Products#
Every source-derived product name is available through these pages.
- 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
- ALCOHOL
- IRIS 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
- ARSENIC CATION (3+)
- BERBERIS VULGARIS ROOT BARK
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2540 | 55714-2540-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 254018c8-fbd6-4825-e063-6394a90a02be | 9d3bb3f0-b923-a1d2-e053-2995a90a0902 | 2024-10-24 | Warnings | 9d3bb3f0-b923-a1d2-e053-2995a90a0902 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
