FDA.reportPublic FDA data

Vitiligo

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:20

Label at a glance#

ProductVitiligo
Active ingredientECHINACEA, 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, IRIS VERSICOLOR ROOT, LYCOPERDON UTRIFORME FRUITING BODY, MUCUNA PRURIENS FRUIT TRICHOME
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, 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

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2592-1Vitiligo30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2592VITILIGO (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 [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240313_136945e2-6f2a-a0df-e063-6294a90a994b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-259255714-2592-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
HURA CREPITANS SAP8UHN1I06UPACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LYCOPERDON UTRIFORME FRUITING BODYK2A74U428FACTIB
MUCUNA PRURIENS FRUIT TRICHOME3E271BSI0CACTIB

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
VitiligoECHINACEA, 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 ALBUMNewton Laboratories, Inc.136945e2-6f2a-a0df-e063-6294a90a994b2024-03-11WarningsExact identifier
ndc (package): 55714-2592-1
ndc (product): 55714-2592
ndc11 (package): 55714259201
spl id: 136939aa-bd34-38a6-e063-6394a90abad0
spl set id: 136945e2-6f2a-a0df-e063-6294a90a994b

Reported adverse events (FAERS/openFDA)#

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