LEADER POISON IVY WASH- pramoxine hydrochloride lotion
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Poison Ivy Wash

Drug Facts

Active ingredient

Pramoxine HCl 1%

Purpose

External analgesic

Uses

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

Warnings

For external use only

When using this product

Avoid contact with the eyes. Do not leave on skin longer than three minutes. rinse throughly after application.

Stop use and ask a doctor if

conditions worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

Adult and children 2 years of age and older. Wet affected areas. Apply the product to affected skin and surrounding area. work foam into a lather and rub for up to 3 minutes, if needed. Do not leave on skin for longer than 3 minutes. throughly rinse product from all areas. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age. Consult a doictor.

Other Information

For best results, use near a shower or sink where it is easy to throughly rinse off product.

Keep out of reach of children

Inactive Ingredients

Water, Ammonium Laurl Sulfate, Distearyl Phtalic Acid Amide, Glycol Distearate, Cocamide MIPA, Propylene Glycol, (and) Diazodinyl Urea (and) Methylparaben (and) Propylparaben, Glycerin, Jojoba Esters, Disodium EDTA, Sodium Hydroxide, Nonoxynol-9.

Questions or Comments?

1-800-662-3435

Removes urishiol from the skin. For best results, use as soon as possible after contact with poisson ivy is suspected.

Principal Display Panel

NDC 49781-105-06
LEADER ®
Poison Ivy Wash
6 FL OZ (177 mL)

Principal Display Panel
NDC 49781-105-06
LEADER®
Poison Ivy Wash
6 FL OZ (177 mL)

LEADER POISON IVY WASH
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49781-105
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49781-105-06	117 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/24/2015	08/31/2022

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	analysis(49781-105) , manufacture(49781-105) , pack(49781-105) , label(49781-105)

Revised: 7/2022

Document Id: e42a2cb8-3fb4-6844-e053-2995a90a59b0

Set id: c0cd4ef5-860f-4035-9f91-fe4f78c33ae2

Version: 3

Effective Time: 20220719

Cardinal Health