FDA.reportPublic FDA data

BODY ACTION PRODUCTS: Prolong Lubricating Gel

Manufacturer
PRODUCT MAX GROUP INC
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:49

Label at a glance#

ProductBODY ACTION PRODUCTS Prolong Lubricating
Active ingredientBENZOCAINE
Label structure7 sections

Indications and uses

Helps in the prevention of premature ejaculation.

Dosage and administration

Apply a small amount to head and shaft of penis before intercourse. Wash product off after intercourse.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Uses

INDICATIONS & USAGE SECTION

  • Helps in the prevention of premature ejaculation.

Warnings

WARNINGS SECTION

For external use only.

  • Avoid contact with the eyes.
  • 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.

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 head and shaft of penis before intercourse.
  • Wash product off after intercourse.

Other Information

SPL UNCLASSIFIED SECTION

Do not use if safety seal under cap is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cellulose Thickener, Methylparaben, PEG-8, Propylene Glycol, Propylparaben, Water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
70742-288-00BODY ACTION PRODUCTS Prolong Lubricating60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70742-288BODY ACTION PRODUCTS PROLONG LUBRICATING (BENZOCAINE) GEL [PRODUCT MAX GROUP INC]2Current NDC, Legacy NDC, 1 package rows20231111_3bef5915-1c98-4011-baa9-ad0bbef200c2.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70742-28870742-288-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
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
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
ndc (package): 70742-288-00
ndc (product): 70742-288
ndc11 (package): 70742028800
spl id: 09d769cf-cc49-9fd3-e063-6394a90ac18e
spl set id: 3bef5915-1c98-4011-baa9-ad0bbef200c2

Reported adverse events (FAERS/openFDA)#

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