Ivarest Poison Ivy Removal And Itch Relief Liquid
FDA Label NDC 10157-2125

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Ivarest Poison Ivy Removal And Itch Relief (NDC 10157-2125). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Pramoxine HCl 1.0% (w/w)

Purpose

External analgesic

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

Warnings

For external use only

When Using This Product

  • 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

Keep out of reach of children.

Directions

  • 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

  • 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

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

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)

* Please review the disclaimer below.