FDA.reportPublic FDA data

Poison Ivy

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:55

Label at a glance#

ProductPoison Ivy
Active ingredientXEROPHYLLUM ASPHODELOIDES, ACONITUM NAPELLUS, SEMECARPUS ANACARDIUM JUICE, APIS MELLIFERA, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CROTON TIGLIUM SEED, GRAPHITE, GRINDELIA HIRSUTULA FLOWERING TOP, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SMILAX ORNATA ROOT, SULFUR, ECHINACEA, UNSPECIFIED, RUMEX CRISPUS ROOT, TARAXACUM OFFICINALE, URTICA URENS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

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 crispus 6x, Taraxacum officinale 6x, Urtica urens 6x, Aconitum napellus 15x, Anacardium occidentale 15x, Apis mellifica 15x, Bryonia 15x, Cantharis 15x, Croton tiglium 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vomica 15x, Ranunculus bulbosus 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x, Xerophyllum asphodeloides 30x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4801-1Poison Ivy30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4801POISON IVY (XEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_99e8ca63-4ec3-92a2-e053-2995a90ac9a6.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-480155714-4801-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
APIS MELLIFERA7S82P3R43ZACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
GRAPHITE4QQN74LH4OACTIB
GRINDELIA HIRSUTULA FLOWERING TOPIDB0NAZ6AIACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
SULFUR70FD1KFU70ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT

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
Poison IvyXEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.Newton Laboratories, Inc.99e8ca63-4ec3-92a2-e053-2995a90ac9a62020-12-07WarningsExact identifier
ndc (package): 55714-4801-1
ndc (product): 55714-4801
ndc11 (package): 55714480101
spl id: b5e2eb33-ec1d-b6b9-e053-2995a90a7384
spl set id: 99e8ca63-4ec3-92a2-e053-2995a90ac9a6

Reported adverse events (FAERS/openFDA)#

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