IVAREST POISON IVY REMOVAL AND ITCH RELIEF- pramoxine hydrochloride liquid

Ivarest Poison Ivy Removal and Itch Relief by

Drug Labeling and Warnings

Ivarest Poison Ivy Removal and Itch Relief by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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

INGREDIENTS AND APPEARANCE

IVAREST POISON IVY REMOVAL AND ITCH RELIEF 
pramoxine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2125-1	1 in 1 CARTON	02/01/2025
1		30 in 1 JAR
1		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	02/01/2025

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-2125)