FDA.reportPublic FDA data

Herpes Sores

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:48

Label at a glance#

ProductHerpes Sores
Active ingredientARSENIC TRIOXIDE, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CHELIDONIUM MAJUS, HELIANTHEMUM CANADENSE, CONIUM MACULATUM FLOWERING TOP, CROTON TIGLIUM SEED, SOLANUM DULCAMARA TOP, GRAPHITE, POTASSIUM DICHROMATE, LYCOPODIUM CLAVATUM SPORE, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, KEROSENE, ANEMONE PULSATILLA, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SMILAX ORNATA ROOT, HYPERICUM PERFORATUM, SEPIA OFFICINALIS JUICE, SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, ECHINACEA, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as itching, tingling, crusting and painful skin eruptions or ulcerations.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Hypericum perforatum 11x, Arsenicum album 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Cistus canadensis 20x, Conium maculatum 20x, Croton tiglium 20x, Dulcamara 20x, Graphites 20x, Kali bichromicum 20x, Lycopodium clavatum 20x, Mezereum 20x, Nux vomica 20x, Petroleum 20x, Pulsatilla 20x, Ranunculus bulbosus 20x, Rhus toxicodendron 20x, Sarsaparilla 20x, Sepia 20x, Sulphur 20x, Thuja occidentalis 20x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as itching, tingling,crusting and painful skin eruptions or ulcerations.

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

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 - PREGNANCY OR BREAST FEEDING SECTION

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4802-1Herpes Sores30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4802HERPES SORES (ARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUM) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201204_99d9133b-6eea-511c-e053-2a95a90a74cb.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-480255714-4802-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
KEROSENE1C89KKC04EACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
WATER059QF0KO0RIACT
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB

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
Herpes SoresARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUMNewton Laboratories, Inc.99d9133b-6eea-511c-e053-2a95a90a74cb2020-12-03WarningsExact identifier
ndc (package): 55714-4802-1
ndc (product): 55714-4802
ndc11 (package): 55714480201
spl id: b594ccb7-140f-8e68-e053-2a95a90a79d4
spl set id: 99d9133b-6eea-511c-e053-2a95a90a74cb

Reported adverse events (FAERS/openFDA)#

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