LEADER POISON IVY WASH- pramoxine hydrochloride lotion lotion

Leader Poison Ivy Wash by

Drug Labeling and Warnings

Leader Poison Ivy Wash by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

When using this product:

• avoid contact with eyes
• do not leave on skin longer than 3 minutes
• rinse thoroughly after application

INACTIVE INGREDIENT

Inactive Ingredients:

Water

Ammonium Lauryl Sulfate

Distearyl Phthalic Acid Amide

Glycol Distearate

Cocamide MIPA

Propylene Glycol

Diazolidinyl Urea

Methylparaben

Propylparaben Glycerin

Jojoba Esters

Disodium EDTA

Sodium Hydroxide

Nonxynol-9

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older:

• Wet the affected area
• Apply product to affected skin and surrounding area
• work foam into a lather and rub for up to 3 minutes, if needed

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

PURPOSE

External Analgesic

ACTIVE INGREDIENT

Pramoxine HCl 1%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER POISON IVY WASH 
pramoxine hydrochloride lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0398
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0398-1	177 mL in 1 CONTAINER; Type 0: Not a Combination Product	02/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2019

Labeler - Cardinal Health (097537435)