FDA.reportPublic FDA data

Vagi-Cure Advanced Sensitive Medicated

Manufacturer
SCI International, Inc. DBA Continental Pharmaceuticals | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2022-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:27

Label at a glance#

ProductVagi-Cure Advanced Sensitive Medicated
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

Temporarily relieves itching

Dosage and administration

adult and children 2 years and older apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. children under 2 years consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine                     5%

Benzalkonium Chloride  .13%

Purpose

OTC - PURPOSE SECTION

External Analgesic

External Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

Avoid contact with 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.

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

adult and children 2 years and older

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

children under 2 years

consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Gel, Carbomer, Cetyl Alcohol, De-ionized Water, Disodium EDTA, Fragrance, Glycerol Monostearate, Isopropyl Myristate, Isopropyl Palmitate, Lanolin Anhydrous, Methylparaben, Mineral Oil, Peg 100 Stearate, Propylene Glycol, Propylparaben, Vitamin E (Tocopheryl Acetate). 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL 

Vagi-Cure

Anti-Itch Cream

Advance Sensitive Medicated Cream

NET WT 0.75oz (21g)

label of vagi-cure advancelabel of vagi-cure advance

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997658benzocaine 5 % / benzalkonium chloride 0.13 % Vaginal CreamPSN2
997658benzalkonium chloride 1.3 MG/ML / benzocaine 50 MG/ML Vaginal CreamSCD2
997658benzalkonium chloride 0.13 % / benzocaine 5 % Vaginal CreamSY2

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
76466-011-072024-01-30C16284748780-19d75b9cf-ea77-f424-e053-dadaa90a57ceVagi-Cure Advanced Sensitive Medicated
76466-011-072022-02-24C16284748780-19d75b9cf-ea77-f424-e053-dadaa90a57ceVagi-Cure Advanced Sensitive Medicated
76466-011-072020-01-31C16284748780-19d75b9cf-ea77-f424-e053-dadaa90a57ceVagi-Cure Advanced Sensitive Medicated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76466-011-07Vagi-Cure Advanced Sensitive Medicated21 g in 1 TUBECREAM212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76466-011VAGI-CURE ADVANCED SENSITIVE MEDICATED (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [SCI INTERNATIONAL, INC. DBA CONTINENTAL PHARMACEUTICALS]2Legacy NDC, 1 package rows20220225_624a948a-8db6-4834-aead-ed8dfbe97e03.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76466-01176466-011-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZOCAINEU3RSY48JW5ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d8c30919-0dee-4c4e-e053-2995a90a0dab624a948a-8db6-4834-aead-ed8dfbe97e032022-02-24WarningsExact identifier
spl id: d8c30919-0dee-4c4e-e053-2995a90a0dab
spl set id: 624a948a-8db6-4834-aead-ed8dfbe97e03

Reported adverse events (FAERS/openFDA)#

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