FDA.reportPublic FDA data

TOXICODENDRON PUBESCENS LEAF

Manufacturer
Schwabe North America, Inc | Schwabe Mexico, S.A. de C.V.
Effective date
2023-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:34:16

Label at a glance#

ProductTOXICODENDRON PUBESCENS LEAF
Active ingredientTOXICODENDRON PUBESCENS LEAF
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Rhus tox (Poison Ivy) 4X

Inactive Ingredient 

INACTIVE INGREDIENT SECTION

ethyl alcohol

purified water

Dosage & Adminstration

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and Children 12 years of age and older: Take 10 drops (0.2 ml) in 2 oz of water every 2 hours as needed.

Children under 12 years of age:  Consult a physician for use.

As symptoms improve, decrease to once every 4 hours, then twice daily until symptoms disappear.

Place mixture of Oral Ivy and water under tongue at least 15 minutes before or half hour after eating, brushing teeth or drinking anything except water.

Indications & Usage 

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of contact dermatitis associated with posion ivy, oak, and sumac, including: itching, red or burning skin rashes, blisters with oozing or crusting, skin irritation, and swelling.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves symptoms of contact dermatitis associated with posion ivy, oak, and sumac, including: itching, red or burning skin rashes, blisters with oozing or crusting, skin irritation, and swelling.

Warnings

WARNINGS SECTION

Do not use if hypersensitive to this or any other ingredients in this product.  This product contains poison ivy (Rhus tox) plant materials.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days. 

Discontinue use and consult a physician. These can be signs of a serious condition. 

Pregnancy and Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

In case of overdose, seek medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBN21900990.A01 Z Oral Ivy Liq 1 oz.jpgLBN21900990.A01 Z Oral Ivy Liq 1 oz.jpg

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Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-199153499-1991-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ALCOHOL3K9958V90MIACT
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
4269b0c6-eaaf-4034-b9e3-931f7c92edf16c04d7c0-3027-4db3-a5c5-a6147cd08add2023-03-09WarningsExact identifier
spl id: 4269b0c6-eaaf-4034-b9e3-931f7c92edf1
spl set id: 6c04d7c0-3027-4db3-a5c5-a6147cd08add

Reported adverse events (FAERS/openFDA)#

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