BLISTEX IVAREST POISON IVY ITCH- zinc acetate and pramoxine hydrochloride spray

Blistex Ivarest Poison Ivy Itch by

Drug Labeling and Warnings

Blistex Ivarest Poison Ivy Itch 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

Active ingredients	Purpose
Pramoxine HCl 1.0% (w/w)	External Analgesic
Zinc Acetate 0.12 % (w/w)	Skin Protectant

Uses

• for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
• dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac

Warnings

For external use only

Do not use

• on large areas of the body

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last 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

• do not use more often than directed.
• as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry.
• apply Ivarest Poison Ivy Itch Spray liberally.
• adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily.
• children under 2 years of age: consult a doctor.

Inactive ingredients

glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, purified water, SD alcohol 38-B, sodium citrate

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

Quick Relief Spray

New!

NDC: 10157-2100-1

MAXIMUM STRENGTH
IVAREST®
EXTERNAL ANALGESIC/SKIN PROTECTANT

POISON IVY
ITCH SPRAY

No Rub,
No Mess
Stays Where You Spray It
To Protect Affected Area

Soothes
Skin Fast
Relieves Itch and Pain,
Comforts Irritated Skin

Poison Ivy, Oak & Sumac,
Insect Bites, Minor Skin Irritations

Net 3.4 fl oz. (100 mL)

INGREDIENTS AND APPEARANCE

BLISTEX IVAREST POISON IVY ITCH 
zinc acetate and pramoxine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	Zinc Acetate	0.12 g  in 100 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
Phenoxyethanol (UNII: HIE492ZZ3T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2100-1	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	02/02/2015

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-2100)