FDA.reportPublic FDA data

Massage Men Gel Max Size

Manufacturer
Valley of the Sun Cosmetics LLC
Effective date
2021-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:14

Label at a glance#

ProductMassage Men Gel Max Size
Active ingredientBENZOCAINE
Label structure12 sections

Indications and uses

helps in the prevention of premature ejaculation helps in temporarily prolonging the time until ejaculation

Dosage and administration

apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse. use only on intact, non-inflamed skin allow gel to dry prior to intercourse not suitable for oral use use as directed, not more than four times per day

Storage and handling

Store between 20-25°C (68-77°F) Compatible with latex condoms Children resistant closure. Instructions for opening are included in the leaflet Read the enclosed leaflet to achieve best results

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Uses

INDICATIONS & USAGE SECTION

  • helps in the prevention of premature ejaculation
  • helps in temporarily prolonging the time until ejaculation

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes.

Stop use and ask doctor

OTC - ASK DOCTOR 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.
  • If you or your partner develop rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.
  • use only on intact, non-inflamed skin
  • allow gel to dry prior to intercourse
  • not suitable for oral use
  • use as directed, not more than four times per day

Other information

STORAGE AND HANDLING SECTION

  • Store between 20-25°C (68-77°F)
  • Compatible with latex condoms
  • Children resistant closure. Instructions for opening are included in the leaflet
  • Read the enclosed leaflet to achieve best results

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, eurycoma longifolia (long jack) root extract, sodium hydroxide

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer boxOuter boxLabelLabel

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
76523-063-152023-01-30C16284748780-1f386c64a-21cc-0266-e053-dadaa90a7c1aMassage Men Gel Max Size

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76523-063-15Massage Men Gel Max Size15 g in 1 BOTTLE, DISPENSINGGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76523-063MASSAGE MEN GEL MAX SIZE (BENZOCAINE) GEL [VALLEY OF THE SUN COSMETICS LLC]1Legacy NDC, 1 package rows20210703_c6188bb5-e989-266a-e053-2995a90a5853.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76523-06376523-063-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
PROPANEDIOL5965N8W85TIACT
EDETATE DISODIUM7FLD91C86KIACT
CARBOMER 9404Q93RCW27EIACT
EURYCOMA LONGIFOLIA ROOT43B8E2HG8BIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
c6188bb5-e98a-266a-e053-2995a90a5853c6188bb5-e989-266a-e053-2995a90a58532021-07-01WarningsExact identifier
spl id: c6188bb5-e98a-266a-e053-2995a90a5853
spl set id: c6188bb5-e989-266a-e053-2995a90a5853

Reported adverse events (FAERS/openFDA)#

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