FDA.reportPublic FDA data

Roman

Manufacturer
Roman Health Ventures Inc.
Effective date
2019-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:04:27

Label at a glance#

ProductRoman Male Genital Desensitizer
Active ingredientBENZOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine USP 4%

OTC - PURPOSE SECTION

Purpose

Male Genital Desensitizer

INDICATIONS & USAGE SECTION

Use

Helps in temporarily prolonging time until ejaculation

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.
  • you or your partner develop a rash or irritation, such as burning or itching
  • symptoms persist.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.

INACTIVE INGREDIENT SECTION

Inactive ingredients ethyl alcohol (SDA 40B), propylene glycol, purified water

SPL UNCLASSIFIED SECTION

Distributed by Roman Health Ventures, Inc.

29 W 30th St. New York, NY 10001

888-798-8686

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ro

BENZOCAINE

MALE GENITAL DESENSITIZER

8 SINGLE USE ENDURANCE WIPES

Benzocaine WipesBenzocaine Wipes

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72484-43272484-432-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZOCAINEU3RSY48JW5ACTIB

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
9615543d-bb74-dd08-e053-2995a90ad2777ba84a4c-79a8-86a6-e053-2a91aa0a85882019-10-29WarningsExact identifier
spl id: 9615543d-bb74-dd08-e053-2995a90ad277
spl set id: 7ba84a4c-79a8-86a6-e053-2a91aa0a8588

Reported adverse events (FAERS/openFDA)#

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