FDA.reportPublic FDA data

Poison Ivy and Poison Oak Relief

Manufacturer
Hyland's Inc.
Effective date
2022-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:18:54

Label at a glance#

ProductPoison Ivy and Poison Oak Relief
Active ingredientTOXICODENDRON PUBESCENS LEAF, CROTON TIGLIUM SEED, XEROPHYLLUM ASPHODELOIDES
Label structure11 sections

Indications and uses

■Temporarily relieves the following symptoms after contact with poison ivy or poison oak: ■ red, swollen eruptions ■ itchy, stinging or burning skin irritations ■ watery blisters sometimes followed by oozing or crusting

Dosage and administration

Adults and children 12 years and over Dissolve 2-3 tablets under tongue every 2 hours for up to 4 doses, then every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1-2 tablets under tongue every 2 hours for up to 4 doses, then every 4 hours until relieved. Children under 6 years Consult a physician.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves Itching, Burning, Swelling, Blisters, Redness and Skin Irritations

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Croton Tig 9X HPUSitching, oozing eruptions
Rhus Tox 6X HPUSred, swollen eruptions with itching, followed by crusting
Xerophyllum 6X HPUSitching, stinging, burning skin irritations

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

■Temporarily relieves the following symptoms after contact with poison ivy or poison oak:
■ red, swollen eruptions ■ itchy, stinging or burning skin irritations
■ watery blisters sometimes followed by oozing or crusting

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - DO NOT USE SECTION

Do not use more than directed.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms such as irritation, pain or redness persist for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

OVERDOSAGE SECTION

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children
12 years and over

Dissolve 2-3 tablets under tongue every 2 hours

for up to 4 doses, then every 4 hours until relieved.

Children 6 years to
under 12 years 		Dissolve 1-2 tablets under tongue every 2 hours
for up to 4 doses, then every 4 hours until relieved.
Children under 6 yearsConsult a physician.

Other information

SPL UNCLASSIFIED SECTION

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Indications and Usage

RECENT MAJOR CHANGES SECTION

 Temporarily relieves the following symptoms after contact with poison ivy or poison oak:
 red, swollen eruptions  itchy, stinging or burning skin irritations
 watery blisters sometimes followed by oozing or crusting

Principal Display Panel - 50 Tablets Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-4003-1

SINCE 1903

Hyland's

POISON IVY &

POISON OAK

RELIEF*

NATURAL ACTIVE INGREDIENTS - GENTLE ON YOU

Relieves Itching, Burning, Swelling,
Blisters, Redness and
Skin Irritations

50 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4003POISON IVY AND POISON OAK RELIEF (CROTON TIGLIUM SEED,TOXICODENDRON PUBESCENS LEAF AND XEROPHYLLUM ASPHODELOIDES) TABLET [HYLAND'S INC.]3Legacy NDC20221217_93cc674a-46ab-c7c0-e053-2a95a90aa344.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-400354973-4003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB

Source Document#

Source XML · Source PDF

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
413b606f-de5c-fd41-e063-6394a90ab1c993cc674a-46ab-c7c0-e053-2a95a90aa3442025-10-15WarningsExact identifier
spl set id: 93cc674a-46ab-c7c0-e053-2a95a90aa344

Reported adverse events (FAERS/openFDA)#

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