PRIVATE LABEL POISON IVY WASH- pramoxine hydrochloride lotion 
Humco Holding Group, Inc.

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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5th & Co. 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, 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

Poison Ivy Label

PRIVATE LABEL POISON IVY WASH 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0802-0119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0802-0119-96117000 mg in 1 BOTTLE; Type 0: Not a Combination Product06/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/18/2018
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0802-0119) , pack(0802-0119) , label(0802-0119) , analysis(0802-0119)

Revised: 6/2020
Document Id: a8862995-5d80-64a6-e053-2a95a90a6ebe
Set id: 6eeebc09-309a-2283-e053-2991aa0acbf6
Version: 2
Effective Time: 20200620
 
Humco Holding Group, Inc.