FDA.reportPublic FDA data

Ivarest Poison Ivy Removal and Itch Relief

Manufacturer
Blistex Inc.
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:07

Label at a glance#

ProductIvarest Poison Ivy Removal and Itch Relief
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Storage and handling

To remove urushiol plant oils from the skin: apply pad and wipe across affected area in one direction repeat the above step using a second pad DO NOT FLUSH – after application, discard pads in trash and wash hands Do not use if seal is broken www.ivarest.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1.0% (w/w)

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • To remove urushiol plant oils from the skin:
    • apply pad and wipe across affected area in one direction
    • repeat the above step using a second pad
  • DO NOT FLUSH – after application, discard pads in trash and wash hands
  • Do not use if seal is broken

www.ivarest.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, ammonium xylenesulfonate, avena sativa (oat) kernel extract, citric acid, decyl glucoside, ethylhexylglycerin, glycerin, hamamelis virginiana (witch hazel) water, phenoxyethanol, polysorbate 60, purified water, SD alcohol 38-B, simethicone, sodium hydroxide, tetrasodium EDTA

PRINCIPAL DISPLAY PANEL - 30 Pad Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IVAREST®

NEW

MAXIMUM STRENGTH

+
POISON IVY
OIL REMOVAL &
ITCH RELIEF PADS
External Analgesic

REMOVES MORE THAN 99% OF URUSHIOL OILS*

IMMEDIATELY CLEANSES & CALMS SKIN

INSTANT ITCH & PAIN RELIEF
FROM OUTDOOR ITCHES

+
DOCTOR
RECOMMENDED

30
PADS

PRINCIPAL DISPLAY PANEL - 30 Pad Jar Carton
PRINCIPAL DISPLAY PANEL - 30 Pad Jar Carton

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2125-1Ivarest Poison Ivy Removal and Itch Relief1 in 1 CARTONLIQUID11
10157-2125-1Ivarest Poison Ivy Removal and Itch Relief30 in 1 JARLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2125IVAREST POISON IVY REMOVAL AND ITCH RELIEF (PRAMOXINE HYDROCHLORIDE) LIQUID [BLISTEX INC.]1Current NDC, 2 package rows20250501_dedbf5d9-0f86-4f32-8321-da86c9838c0a.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-212510157-2125-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
OATZ6J799EAJKIACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
POLYSORBATE 60CAL22UVI4MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
ndc (package): 10157-2125-1
ndc (product): 10157-2125
ndc11 (package): 10157212501
spl id: 61e42ae1-bdd5-43fb-a98e-3d28f0651074
spl set id: dedbf5d9-0f86-4f32-8321-da86c9838c0a

Reported adverse events (FAERS/openFDA)#

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