FDA.reportPublic FDA data

POWERECT Benzocaine Male Delay Gel

Manufacturer
SKINS SEXUAL HEALTH LIMITED
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:21

Label at a glance#

ProductPOWERECT Benzocaine Male Delay Gel
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

Helps to temporarily prevent premature ejaculation.

Dosage and administration

Apply product to the head and shaft of the penis prior to intercourse, or as directed by your physician. Wipe away excess product.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5.00%

Purpose:

OTC - PURPOSE SECTION

Male genital desensitizer

USES:

INDICATIONS & USAGE SECTION

Helps to temporarily prevent premature ejaculation.

WARNINGS:

WARNINGS SECTION

Premature ejaculation may be due to a condition requiring medical supervision. If this product, when used as directed, does not provide relief, discontinue use and consult a physician. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a physician.

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply product to the head and shaft of the penis prior to intercourse, or as directed by your physician. Wipe away excess product.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua (deionized Water), Ethylhexylglycerin, Hydroxyethylcellulose, l-Arginine, Lepidium Meyenii (Maca) Extract, Panax Ginseng Root Extract, PEG-8, Phenoxyethanol, Propylene Glycol.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Store in a cool dry place below 30°C (86°F) out of direct sunlight.

QUESTIONS?

OTC - QUESTIONS SECTION

Contact us on +44 1636 593943

Package Labeling:3ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

Package Labeling:15ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81923-367-00POWERECT Benzocaine Male Delay Gel3 mL in 1 PACKETGEL33
81923-367-01POWERECT Benzocaine Male Delay Gel15 mL in 1 BOTTLEGEL153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-367POWERECT BENZOCAINE MALE DELAY GEL (BENZOCAINE) GEL [SKINS SEXUAL HEALTH LIMITED]3Current NDC, Legacy NDC, 2 package rows20240717_2fafe1f2-a31e-4b2a-bc51-81e16b319c3a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81923-36781923-367-00, 81923-367-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ARGININE94ZLA3W45FIACT
ASIAN GINSENGCUQ3A77YXIIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
ndc (package): 81923-367-01
ndc (package): 81923-367-00
ndc (product): 81923-367
ndc11 (package): 81923036701
ndc11 (package): 81923036700
spl id: 1d5bbd54-69df-3338-e063-6294a90a53bf
spl set id: 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a

Reported adverse events (FAERS/openFDA)#

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