Ivarest®

Ivarest®
SPL v1
SPL
SPL Set ID dedbf5d9-0f86-4f32-8321-da86c9838c0a
Route
TOPICAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g)
Inactive Ingredients
Water Alcohol Glycerin Oat Ammonium Xylenesulfonate Decyl Glucoside Hamamelis Virginiana Top Water Polysorbate 60 Phenoxyethanol Ethylhexylglycerin Citric Acid Monohydrate Sodium Hydroxide Edetate Sodium Aloe Vera Leaf Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Warnings

For external use only

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.
Active Ingredient

Pramoxine HCl 1.0% (w/w)

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

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.
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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

External analgesic

Warnings

For external use only

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.
Active Ingredient (Active ingredient)

Pramoxine HCl 1.0% (w/w)

Other Information (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 (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

When Using This Product (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.
Principal Display Panel 30 Pad Jar Carton (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


Advanced Ingredient Data


Raw Label Data

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