FDA.reportPublic FDA data

Rashes-Hives

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:08

Label at a glance#

ProductRashes-Hives
Active ingredientSMILAX ORNATA ROOT, ANTIMONY TRISULFIDE, APIS MELLIFERA, ARSENIC TRIOXIDE, BERBERIS VULGARIS ROOT BARK, LYCOPERDON UTRIFORME FRUITING BODY, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CHELIDONIUM MAJUS, CROTON TIGLIUM SEED, SOLANUM DULCAMARA TOP, GRAPHITE, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, KEROSENE, PULEX IRRITANS, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, SULFUR, ECHINACEA, UNSPECIFIED, URTICA URENS, RUMEX CRISPUS ROOT, TARAXACUM OFFICINALE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptom such as burning, itching, redness, swelling and discomfort.

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 6x, Rumex crisp. 6x, Taraxacum 6x, Urtica ur.6x. Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as burning, itching, redness, swelling and discomfort.

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
55714-4761-1Rashes-Hives30 mL in 1 BOTTLE, GLASSLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-476155714-4761-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SMILAX ORNATA ROOT2H1576D5WGACTIB
ALCOHOL3K9958V90MIACT
ANTIMONY TRISULFIDEF79059A38UACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
LYCOPERDON UTRIFORME FRUITING BODYK2A74U428FACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
KEROSENE1C89KKC04EACTIB
PULEX IRRITANSL63DD62R8RACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SULFUR70FD1KFU70ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
URTICA URENSIHN2NQ5OF9ACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
TARAXACUM OFFICINALE39981FM375ACTIB

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
Rashes-HivesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9988637d-d023-399e-e053-2a95a90abca62025-09-29WarningsExact identifier
ndc (package): 55714-4761-1
ndc (product): 55714-4761
ndc11 (package): 55714476101
spl id: 3ff70177-c248-baba-e063-6394a90afe61
spl set id: 9988637d-d023-399e-e053-2a95a90abca6

Reported adverse events (FAERS/openFDA)#

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