FDA.reportPublic FDA data

Vagicaine Maximum Strength Anti-Itch Cream

Manufacturer
CVS Pharmacy | BioZone Laboratories, Inc. | BioZone Laboratories, Inc
Effective date
2016-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:50

Label at a glance#

ProductVagicaine Maximum Strength Anti-Itch Cream
Active ingredientBENZOCAINE, RESORCINOL
Label structure8 sections

Dosage and administration

adults and children 12 years and older apply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily children under 12 years ask a doctor

Storage and handling

store at 20º-25ºC (68º - 77ºF)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Resorcinol 3%

Purpose

OTC - PURPOSE SECTION

External Analgesic

External Analgesic

INDICATIONS & USAGE SECTION

Temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - DO NOT USE SECTION

Do not apply over large areas of the body

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

adults and children 12 years and olderapply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily
children under 12 yearsask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20º-25ºC (68º - 77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

Vagicaine

Medicated anti-itch cream

Net Wt 1 oz (28g)

CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.

*This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02995

(c) 2016 CVS/pharmacy

CVS.com (R) 1-800-SHOP CVS V-31535

CVS (R) Quality

Money Back Guarantee

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN1
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD1
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-588-012020-01-31C16284748780-19d75b9d0-cf52-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-588-01Vagicaine Maximum Strength Anti-Itch Cream28 g in 1 TUBECREAM281
59779-588-01Vagicaine Maximum Strength Anti-Itch Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-588VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM (BENZOCAINE, RESORCINOL) CREAM [CVS PHARMACY]1Legacy NDC, 2 package rows20160501_30c61c70-abe3-2950-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-58859779-588-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-40 HYDROGENATED LANOLIN959P5CXE48IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)L605B5892VIACT
XANTHAN GUMTTV12P4NEEIACT
MALTODEXTRIN7CVR7L4A2DIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
BENZOCAINEU3RSY48JW5ACTIB
RESORCINOLYUL4LO94HKACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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
2ff99437-1058-56fc-e054-00144ff88e8830c61c70-abe3-2950-e054-00144ff88e882016-04-18WarningsExact identifier
spl id: 2ff99437-1058-56fc-e054-00144ff88e88
spl set id: 30c61c70-abe3-2950-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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