PRIVATE LABEL POISON IVY WASH- pramoxine hydrochloride lotion

Private Label Poison Ivy Wash by

Drug Labeling and Warnings

Private Label Poison Ivy Wash by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Pramoxine HCl 1%

Purpose

External analgesic

Uses

For temporary relief of pain and itching associated with poison ivy, poison oak, and 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 worsen 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. Thoughly rinse product from all areas. Apply to affected are not more than 3 to 4 times daily. Children under 2 years of age. Consult a doctor.

Other Information

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

Keep out of reach of children

Inactive Ingredients

Water, Ammonium Laurl Sulfate, Distearyl Phtalic Acid Amide, Glyco 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 Urushiol from the skin. For best results, use as soon as possible after contact with poison ivy is suspected.

5th & Co. Poison Ivy Wash

INGREDIENTS AND APPEARANCE

PRIVATE LABEL POISON IVY WASH 
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0802-0119
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0802-0119-96	117000 mg in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/18/2018

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0802-0119) , pack(0802-0119) , label(0802-0119) , analysis(0802-0119)