IVAREST- zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream

Ivarest by

Drug Labeling and Warnings

Ivarest 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
Calamine 14.0 % (w/w)	Skin protectant
Benzyl Alcohol 10.5 % (w/w)	External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w)	External analgesic

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
• with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

• on chicken pox
• on measles

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 liberally to form a layer you can not see through.
• 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.

Other information

Avoid contact with clothing. Ivarest may stain certain fabrics.

Inactive ingredients

bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, PEG-4, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6

PRINCIPAL DISPLAY PANEL - 56g Tube Carton

2 Itch Relievers

NDC: 10157-9077-1

MAXIMUM STRENGTH
IVAREST®
EXTERNAL ANALGESIC/
POISON IVY, OAK, SUMAC DRYING CREAM

POISON IVY
ITCH RELIEF

8 Hour
Relief

MEDICATED ANTI-ITCH CREAM

Double
Relief
Formula

1 Antihistamine
helps stop the reaction
2 Analgesic
soothes itch fast

PLUS Skin protectant to help dry the rash

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

NET WT 2 OZ(56g)

INGREDIENTS AND APPEARANCE

IVAREST 
zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	14 g  in 100 g
Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH)	Benzyl Alcohol	10.5 g  in 100 g
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
bentonite (UNII: A3N5ZCN45C)
benzethonium chloride (UNII: PH41D05744)
lanolin alcohols (UNII: 884C3FA9HE)
lanolin oil (UNII: OVV5IIJ58F)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
petrolatum (UNII: 4T6H12BN9U)
polyethylene glycol 200 (UNII: R95B8J264J)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
polysorbate 60 (UNII: CAL22UVI4M)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
D&C red no. 33 (UNII: 9DBA0SBB0L)
sorbitan monostearate (UNII: NVZ4I0H58X)
squalane (UNII: GW89575KF9)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C yellow no. 6 (UNII: H77VEI93A8)
camphor (synthetic) (UNII: 5TJD82A1ET)
povidone-iodine (UNII: 85H0HZU99M)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9077-1	1 in 1 CARTON	12/31/2007
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/31/2007

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-9077)