Ivarest

Manufacturer
Blistex Inc
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:34

Label at a glance#

ProductIvarest
Active ingredientZinc Oxide, Benzyl Alcohol, Diphenhydramine Hydrochloride
Label structure8 sections

Indications and 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

Dosage and administration

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.

Storage and handling

Avoid contact with clothing. Ivarest may stain certain fabrics.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Avoid contact with clothing. Ivarest may stain certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Long Lasting Cream

NDC 10157-9077-1

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

POISON IVY
ITCH CREAM

8 Hour
Relief

Double
Relief
Formula

  • Antihistamine
    helps stop the reaction
  • 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. (56 g)

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298467calamine 14 % / benzyl alcohol 10.5 % / diphenhydrAMINE HCl 2 % Topical CreamPSN3
1298467benzyl alcohol 0.105 ML/ML / calamine 140 MG/ML / diphenhydramine hydrochloride 20 MG/ML Topical CreamSCD3
1298467benzyl alcohol 10.5 % / calamine 14 % / diphenhydramine hydrochloride 2 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9077-1Ivarest1 in 1 CARTONCREAM13
10157-9077-1Ivarest56 g in 1 TUBECREAM563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9077IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]3Current NDC, Legacy NDC, 2 package rows20240719_6f68cbbb-6269-4bb3-8cc9-50b146703b42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzyl AlcoholACTIVE INGREDIENTLKG8494WBH1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD401
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Benzyl AlcoholACTIVE MOIETYLKG8494WBH1
DiphenhydramineACTIVE MOIETY8GTS82S83M1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
bentoniteINACTIVE INGREDIENTA3N5ZCN45C1
benzethonium chlorideINACTIVE INGREDIENTPH41D057441
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ET1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1M1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A81
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%)INACTIVE INGREDIENT86FQE96TZ41
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HE1
lanolin oilINACTIVE INGREDIENTOVV5IIJ58F1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NC1
mentholINACTIVE INGREDIENTL7T10EIP3A1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
polyethylene glycol 200INACTIVE INGREDIENTR95B8J264J1
polyglyceryl-3 diisostearateINACTIVE INGREDIENT46P231IQV81
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
povidone-iodineINACTIVE INGREDIENT85H0HZU99M1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
squalaneINACTIVE INGREDIENTGW89575KF91
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-907710157-9077-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
lanolin oilLANOLIN OILOVV5IIJ58FCREAM / TOPICAL143 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
polyethylene glycol 200POLYETHYLENE GLYCOL 200R95B8J264JOINTMENT / TOPICAL39 %w/wExact identifier — unii+route
2 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzethonium chlorideBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
lanolin oilLANOLIN OILOVV5IIJ58FCREAM / TOPICAL143 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
camphor (synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
camphor (synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzethonium chlorideBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
bentoniteBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii+route
8 equally ranked IID candidates
polyethylene glycol 200POLYETHYLENE GLYCOL 200R95B8J264JOINTMENT / TOPICAL39 %w/wExact identifier — unii+route
2 equally ranked IID candidates
camphor (synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
bentoniteBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii+route
8 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
camphor (synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
ndc (package): 10157-9077-1
ndc (product): 10157-9077
ndc11 (package): 10157907701
spl id: 3f9296ee-f86d-4ca4-922d-1b6926de869d
spl set id: 6f68cbbb-6269-4bb3-8cc9-50b146703b42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.