FDA.reportPublic FDA data

JO Prolonger with Benzocaine

Manufacturer
CC Wellness LLC
Effective date
2025-09-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:13:38

Label at a glance#

ProductJO Prolonger with Benzocaine
Active ingredientBENZOCAINE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 7.5%

OTC - PURPOSE SECTION

Male Genital Desensitizer

INDICATIONS & USAGE SECTION

For temporary male genital desensitization

Helps to slow the onset of ejaculation

Compatible with natural rubber latex and polyisoprene condoms

For external use only

WARNINGS SECTION

Avoid Contact with the eyes

WARNINGS SECTION

Allergy alert: do not use this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients

WARNINGS SECTION

Do not use on broken or inflamed skin

WARNINGS SECTION

Ask a doctor before use

OTC - ASK DOCTOR SECTION

If your partner is pregnant

If you have or have had liver or kidney problems

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes or nostrils
  • Do not inhale
  • Do not exceed a maximum of 20 sprays in 24 hours
  • Always use the minimum amount effective for you
  • Allow 5-15 minutes to dry prior to intercourse

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 a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Can be used for sexcual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Wash product off after intercourse.

Other information:

OTHER SAFETY INFORMATION

Do not expose to heat or flame.

Store at 20-30°C (68-77°F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

PEG-8, Propylene Glycol, Water (Aqua)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display PanelPrinciple Display Panel

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
71683-004-012024-01-30C16284748780-11030e365-2224-111a-e063-dadaa90a10e2d955f612-1267-f1be-e053-2995a90a5345

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71683-004-01JO Prolonger with Benzocaine1 in 1 BOXSPRAY13
71683-004-02JO Prolonger with Benzocaine60 mL in 1 BOTTLE, SPRAYSPRAY603

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
71683-00471683-004-02, 71683-004-01

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
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
ndc (package): 71683-004-01
ndc (package): 71683-004-02
ndc (product): 71683-004
ndc11 (package): 71683000402
ndc11 (package): 71683000401
spl id: 3e9d73b4-5174-617d-e063-6294a90ad0e9
spl set id: d955f612-1267-f1be-e053-2995a90a5345

Reported adverse events (FAERS/openFDA)#

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