FDA.reportPublic FDA data

REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

Manufacturer
Dolgencorp, Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2016-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:16

Label at a glance#

ProductREXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH
Active ingredientBENZOCAINE, RESORCINOL
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Resorcinol 3%

Purpose

OTC - PURPOSE SECTION

External Analgesic

External Analgesic

Use

INDICATIONS & USAGE SECTION

  • Temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Also, do not use if you have an unusual or abnormal vaginal discharge except under the supervision of a physician.

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 older

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

children under 12 years

consult a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, carbomer, cetyl alcohol, corn oil, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E & D

Principal display panel - 28 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

label of anti-itchlabel of anti-itch

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
55910-415-032020-01-31C16284748780-19d75b9cf-f434-f424-e053-dadaa90a57ceREXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-415-03REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-415REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH (BENZOCAINE AND RESORCINOL) CREAM [DOLGENCORP, INC.]1Legacy NDC, 1 package rows20160928_6f0adbd8-997d-4c56-845e-82f721b19463.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-41555910-415-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
CORN OIL8470G57WFMIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BENZOCAINEU3RSY48JW5ACTIB
RESORCINOLYUL4LO94HKACTIB

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
3d941002-457d-304e-e054-00144ff8d46c6f0adbd8-997d-4c56-845e-82f721b194632016-09-28WarningsExact identifier
spl id: 3d941002-457d-304e-e054-00144ff8d46c
spl set id: 6f0adbd8-997d-4c56-845e-82f721b19463

Reported adverse events (FAERS/openFDA)#

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