FDA.reportPublic FDA data

Prolong Plus

Manufacturer
WSM Investment LL. Topco Sales | WSM Investment LLC. Topco Sales
Effective date
2017-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:33

Label at a glance#

ProductProlong Plus
Active ingredientBENZOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine - 7.5%

OTC - PURPOSE SECTION

Male Genital Desensitizer

INDICATIONS & USAGE SECTION

Helps in temporarily slowing the onset of ejaculation.

WARNINGS SECTION

  • Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • Discontinue use if you or your partner develops rash or irritation, such as burning or itching.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • If this product, used as directed, does not provide relief, discontinue use and consult a doctor.

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor.
  • Rub product into the skin of the penis until it is absorbed.
  • Remove any excess to avoid any unwanted numbing before intercourse.
  • Wash product off after intercourse.

OTHER SAFETY INFORMATION

  • Store at room temperature 20°-25°C (68°-77°F).
  • Tamper-Evident: Do not use if seal under cap is broken or missing.

INACTIVE INGREDIENT SECTION

Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1033007 (1)1033007 (1)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247294benzocaine 7.5 % Topical CreamPSN1
247294benzocaine 75 MG/ML Topical CreamSCD1
247294benzocaine 7.5 % Topical 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
69797-104-012020-01-31C16284748780-19d75b9d0-f289-f424-e053-dadaa90a57ce60b7577d-53a9-4f6f-e053-2991aa0a4480

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69797-104-01Prolong Plus56 g in 1 TUBECREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69797-104PROLONG PLUS (BENZOCAINE) CREAM [WSM INVESTMENT LL. TOPCO SALES]1Legacy NDC, 1 package rows20171220_60b7577d-53a9-4f6f-e053-2991aa0a4480.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69797-10469797-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
AMERICAN GINSENG8W75VCV53QIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT

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
60b7577d-53aa-4f6f-e053-2991aa0a448060b7577d-53a9-4f6f-e053-2991aa0a44802017-12-19WarningsExact identifier
spl id: 60b7577d-53aa-4f6f-e053-2991aa0a4480
spl set id: 60b7577d-53a9-4f6f-e053-2991aa0a4480

Reported adverse events (FAERS/openFDA)#

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