FDA.reportPublic FDA data

CVS Pharmacy

Manufacturer
CVS Pharmacy
Effective date
2017-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:26

Label at a glance#

ProductCVS Pharmacy Sensitive Medicated Cream
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

First aid temporary relief from the discomforts affecting the external area surrounding the vagina: Itching Burning Irritation Skin infections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredients

Benzocaine 5%

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

  • Itching
  • Burning
  • Irritation
  • Skin infections

Warnings

WARNINGS SECTION

For external use only.

Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

When using this product

OTC - WHEN USING SECTION

  • Wash hand thoroughly with soap and water before and after use
  • Avoid contact with eyes.
  • If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
  • Do not use more than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
  • side effect occur. You may report sude effect to FDA at 1-800-FDA-1088

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 immediately. If in eyes, flush with water for 15 minutes and call a physician.

OTC - WHEN USING SECTION

  • Apply to the affected area.
  • Because the area may already be irritated you could experience a slight burning sensation. If this persists more than a few minutes, remove cream and discontinue use.
  • Wash hand thoroughly with soap and water before and after use.

OTHER SAFETY INFORMATION

Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

INACTIVE INGREDIENT SECTION

Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

Questions or Comments

OTC - QUESTIONS SECTION

1-800-635-3696

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and over: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years: Do not use-consult a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube and cartontube and carton

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-638-01CVS PharmacySensitive Medicated Cream42.5 g in 1 TUBECREAM42.52
69842-638-01CVS PharmacySensitive Medicated Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-638CVS PHARMACY SENSITIVE MEDICATED CREAM (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [CVS PHARMACY]2Current NDC, Legacy NDC, 2 package rows20170112_454c3458-7e40-0e5e-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-63869842-638-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOPROPYL STEARATE43253ZW1MZIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
TRISODIUM HEDTAK3E0U7O8KIIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
CVS Pharmacy Sensitive Medicated CreamBENZOCAINE, BENZALKONIUM CHLORIDECVS Pharmacy454c3458-7e40-0e5e-e054-00144ff8d46c2017-01-04WarningsExact identifier
ndc (package): 69842-638-01
ndc (product): 69842-638
ndc11 (package): 69842063801
spl id: 45d94180-4436-7298-e054-00144ff88e88
spl set id: 454c3458-7e40-0e5e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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