FDA.reportPublic FDA data

Private Label Poison Ivy Wash

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:29

Label at a glance#

ProductPrivate Label Poison Ivy Wash
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

Adult and children 2 years of age and older. Wet affected areas. Apply the product to affected skin and surrounding area. Work foam into a lather and rub for up to 3 minutes, if needed. Do not leave on skin for longer than 3 minutes. Thoughly rinse product from all areas. Apply to affected are not more than 3 to 4 times daily. Children under 2 years of age. Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes. Do not leave on skin longer than three minutes. Rinse throughly after application.

Stop use and ask a doctor if

OTC - STOP USE SECTION

conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older. Wet affected areas. Apply the product to affected skin and surrounding area. Work foam into a lather and rub for up to 3 minutes, if needed. Do not leave on skin for longer than 3 minutes. Thoughly rinse product from all areas. Apply to affected are not more than 3 to 4 times daily. Children under 2 years of age. Consult a doctor.

Other Information

OTHER SAFETY INFORMATION

For best results, use near a shower or sink where it is easy to thoughly rinse off product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Ammonium Laurl Sulfate, Distearyl Phtalic Acid Amide, Glyco Distearate, Cocamide MIPA, Propylene Glycol, (and) Diazodinyl Urea (and) Methylparaben (and) Propylparaben, Glycerin, Jojoba Esters, Disodium EDTA, Sodium Hydroxide, Nonoxynol-9.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-662-3435

Removes Urushiol from the skin. For best results, use as soon as possible after contact with poison ivy is suspected.

5th & Co. Poison Ivy Wash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Poison Ivy LabelPoison Ivy Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247251pramoxine HCl 1 % Medicated Liquid SoapPSN2
1247251pramoxine hydrochloride 10 MG/ML Medicated Liquid SoapSCD2
1247251pramoxine hydrochloride 1 % Medicated Liquid SoapSY2

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
0802-0119-962022-07-29C16284748780-1e4f33bdf-9b39-d8a0-e053-dadaa90a6e4e5th & Co. Poison Ivy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0802-0119-96Private Label Poison Ivy Wash117000 mg in 1 BOTTLELOTION1170002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0802-0119PRIVATE LABEL POISON IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]2Legacy NDC, 1 package rows20200622_6eeebc09-309a-2283-e053-2991aa0acbf6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0802-01190802-0119-96

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
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
EDETATE DISODIUM7FLD91C86KIACT
NONOXYNOL-948Q180SH9TIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCOL DISTEARATE13W7MDN21WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM HYDROXIDE55X04QC32IIACT
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
a8862995-5d80-64a6-e053-2a95a90a6ebe6eeebc09-309a-2283-e053-2991aa0acbf62020-06-20WarningsExact identifier
spl id: a8862995-5d80-64a6-e053-2a95a90a6ebe
spl set id: 6eeebc09-309a-2283-e053-2991aa0acbf6

Reported adverse events (FAERS/openFDA)#

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