BLISTEX IVAREST MEDICATED POISON IVY CLEANSING FOAM- menthol soap

Blistex by

Drug Labeling and Warnings

Blistex by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 1.0% (w/w)

Purpose

External analgesic

Uses

• for the temporary relief of pain and itching
• soothes and cools skin

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

• adults and children 2 years of age and older: apply to affected area, gently rubbing to remove urushiol (toxic plant oil). Rinse under running water.
• apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: Ask a doctor

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)

INGREDIENTS AND APPEARANCE

BLISTEX   IVAREST MEDICATED POISON IVY CLEANSING FOAM
menthol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9012-2	177 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2008

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-9012)