FDA.reportPublic FDA data

Leader Poison Ivy Wash

Manufacturer
Cardinal Health, 110 dba Leader
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:24

Label at a glance#

ProductLeader Poison Ivy Wash
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

When using this product:

  • avoid contact with eyes
  • do not leave on skin longer than 3 minutes
  • rinse thoroughly after application

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water

Ammonium Lauryl Sulfate

Distearyl Phthalic Acid Amide

Glycol Distearate

Cocamide MIPA

Propylene Glycol

Diazolidinyl Urea

Methylparaben

Propylparaben Glycerin

Jojoba Esters

Disodium EDTA

Sodium Hydroxide

Nonxynol-9

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • Wet the affected area
  • Apply product to affected skin and surrounding area
  • work foam into a lather and rub for up to 3 minutes, if needed

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

OTC - PURPOSE SECTION

External Analgesic

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ivywashivywash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247251pramoxine HCl 1 % Medicated Liquid SoapPSN5
1247251pramoxine hydrochloride 10 MG/ML Medicated Liquid SoapSCD5
1247251pramoxine hydrochloride 1 % Medicated Liquid SoapSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0398-12024-05-13C16284748780-11030e365-2783-111a-e063-dadaa90a10e2LEADER Poison Ivy Wash
70000-0398-12024-01-30C16284748780-11030e365-2783-111a-e063-dadaa90a10e2LEADER Poison Ivy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0398-1Leader Poison Ivy Wash177 mL in 1 CONTAINERLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0398LEADER POISON IVY WASH (PRAMOXINE HYDROCHLORIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20240514_81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0398-1ML - Milliliter70000-03983f5dd1df-c82a-4f86-8c78-d2fecc95c72a12019-11-12

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-039870000-0398-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCOL DISTEARATE13W7MDN21WIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
NONOXYNOL-948Q180SH9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
ndc (package): 70000-0398-1
ndc (product): 70000-0398
ndc11 (package): 70000039801
spl id: 1855aebf-a13d-5bc2-e063-6394a90a3296
spl set id: 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c

Reported adverse events (FAERS/openFDA)#

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