VAGISIL Anti-Itch Medicated Creme Maximum Strength

Manufacturer
Combe Incorporated
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:41:41

Label at a glance#

ProductVAGISIL Anti-Itch Medicated Creme Maximum Strength
Active ingredientBENZOCAINE, RESORCINOL
Label structure13 sections

Dosage and administration

adults and children 12 years and older           Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. children under 12 years consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

VAGISIL Maximum Strength Anti-Itch Creme

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

External analgesic

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Resorcinol 3%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

Allergy Allert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.

Avoid contact with eyes

in case of contact rinse thoroughly and immediately with water.

Stop use and ask doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12
years and older          

Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.
children under 12 yearsconsult a doctor

Other Information:

OTHER SAFETY INFORMATION

questions? call 1-800-431-2610, 9 am to 5 pm est

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vagisil®
Maximum Strength
Anti-Itch Creme

Net Wt. 1 oz. (28 g)

Principal Display Panel Vagisil® Maximum Strength Anti-Itch Creme Net Wt. 1 oz. (28 g)Principal Display Panel Vagisil® Maximum Strength Anti-Itch Creme Net Wt. 1 oz. (28 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN9
1247441Vagisil Maximum Strength 20 % / 3 % Vaginal CreamPSN9
1247441benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal Cream [Vagisil Original Formula]SBD9
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD9
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY9
1247441Vagisil Maximum Strength (benzocaine 20 % / resorcinol 3 % ) Vaginal CreamSY9
1247441Vagisil, Maximum Strength, Anti-Itch Topical CreamSY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11509-4402-12020-04-20C16284748780-19d75b9d0-ed22-f424-e053-dadaa90a57ceVagisil Maximum Strength Anti-Itch Creme
11509-4402-12020-01-31C16284748780-19d75b9d0-ed22-f424-e053-dadaa90a57ceVagisil Maximum Strength Anti-Itch Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-4402-1VAGISIL Anti-Itch Medicated Creme Maximum Strength1 in 1 CARTONCREAM19
11509-4402-1VAGISIL Anti-Itch Medicated Creme Maximum Strength28 g in 1 TUBECREAM289

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-4402VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]9Current NDC, Legacy NDC, 2 package rows20241211_bb73ebd7-ceb0-4b54-9e8f-77486d9037fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-4402-1GM - Gram11509-4402220844e9-5407-48f4-922a-790ee69a58f412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW54
RESORCINOLACTIVE INGREDIENTYUL4LO94HK4
BENZOCAINEACTIVE MOIETYU3RSY48JW54
RESORCINOLACTIVE MOIETYYUL4LO94HK4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK314
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF414
CORN OILINACTIVE INGREDIENT8470G57WFM4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS4
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M4
ISOPROPYL STEARATEINACTIVE INGREDIENT43253ZW1MZ4
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3G4
TRISODIUM HEDTAINACTIVE INGREDIENTK3E0U7O8KI4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11509-440211509-4402-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 2 · 66 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM SULFITESODIUM SULFITEVTK01UQK3GCREAM / TOPICAL8 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
30 equally ranked IID candidates
TRISODIUM HEDTATRISODIUM HEDTAK3E0U7O8KISOLUTION / TOPICAL0.4 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
30 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM SULFITESODIUM SULFITEVTK01UQK3GCREAM / TOPICAL8 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
30 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRISODIUM HEDTATRISODIUM HEDTAK3E0U7O8KISOAP / TOPICAL0.4 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31CREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRISODIUM HEDTATRISODIUM HEDTAK3E0U7O8KISOLUTION / TOPICAL0.4 %w/wExact identifier — unii+route
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRISODIUM HEDTATRISODIUM HEDTAK3E0U7O8KISOAP / TOPICAL0.4 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact 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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31CREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
30 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact 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
VAGISIL Anti-Itch Medicated Creme Maximum StrengthBENZOCAINE AND RESORCINOLCombe Incorporatedbb73ebd7-ceb0-4b54-9e8f-77486d9037fb2024-12-12WarningsExact identifier
ndc (package): 11509-4402-1
ndc (product): 11509-4402
ndc11 (package): 11509440201
spl id: c2295da1-a600-4d65-98b2-6c81fb08c6c0
spl set id: bb73ebd7-ceb0-4b54-9e8f-77486d9037fb

Reported adverse events (FAERS/openFDA)#

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