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

Drug Facts

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

Uses

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

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)

Principal Display Panel - 56g Tube Carton
IVAREST 
zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide14 g  in 100 g
Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol10.5 g  in 100 g
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9077-11 in 1 CARTON12/31/2007
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/31/2007
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9077)

Revised: 12/2019
Document Id: 25cfcb6e-4432-4cbd-936e-0d0d3c39d0f5
Set id: 6f68cbbb-6269-4bb3-8cc9-50b146703b42
Version: 2
Effective Time: 20191227
 
Blistex Inc