BLISTEX  IVAREST MEDICATED POISON IVY CLEANSING FOAM- menthol soap 
Blistex 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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Blistex
Ivarest® Medicated Poison Ivy Cleansing Foam

Drug Facts

Active ingredient

Menthol 1.0% (w/w)

Purpose

External analgesic

Uses

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

acetamide MEA, cocamidopropyl betaine, disodium EDTA, DMDM hydantoin, glycerin, lactamide MEA, PEG-4, PEG-40 hydrogenated castor oil, phenoxyethanol, purified water, sodium lauroyl sarcosinate, triclosan

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

NDC 10157-9012-2

IVAREST®
EXTERNAL ANALGESIC

MEDICATED
POISON IVY
CLEANSING FOAM

Prevents
Outbreaks
if used shortly
after exposure

Soothes &
Comforts Skin
if symptoms have
already developed

For Poison Ivy, Oak & Sumac

Non-Abrasive
Cooling Cleanser

6 FL OZ (177mL)

Principal Display Panel - 177 mL Bottle Label
BLISTEX   IVAREST MEDICATED POISON IVY CLEANSING FOAM
menthol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD)  
N-LACTOYL ETHANOLAMINE (UNII: 900T44YNC7)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRICLOSAN (UNII: 4NM5039Y5X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9012-2177 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2008
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9012)

Revised: 11/2013
Document Id: c88c222a-c422-45e1-8617-8f938051a1a5
Set id: 296192d6-b4e0-40ce-a721-06dd10669ceb
Version: 1
Effective Time: 20131119
 
Blistex Inc