POISON IVY WASH- pramoxine hcl lotion

Poison Ivy Wash by

Drug Labeling and Warnings

Poison Ivy Wash by is a Otc medication manufactured, distributed, or labeled by Chain Drug Market Association, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine HCl 1%

PURPOSE

External Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only.

When using this product:

Avoid Contact with eyes.

Do not leave on skin longer than 3 minutes

Rinse thoroughly after application

WHEN USING

When using this product avoid contact with the eyes. Do not leave on skin longer than 3 minutes. Rinse thoroughly after application.

ASK DOCTOR

Stop use and ask a doctor if condition worses, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 lather and rub for up to 3 minutes if needed. do not leave on skin for longer than 3 minutes. Thoroughly rinse product form all areas. Apply to affected are not more than 3 to 4 times daily.

INACTIVE INGREDIENT

Water

ammonium lauryl sulfare

distearyl phtalic acid amide

glycol distereate

cocamide MIPA

Propylene glycol

Diazolidyn Urea

Methylparaben
Propylparaben

Glycerin

Jojoba esters

disodium edta

sodium hydroxide

nonoxynol-9

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POISON IVY WASH 
pramoxine hcl lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-877
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
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
NONOXYNOL-9 (UNII: 48Q180SH9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-877-06	177 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/24/2019

Labeler - Chain Drug Market Association (011920774)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	manufacture(63868-877) , pack(63868-877) , analysis(63868-877) , label(63868-877)