FDA.reportPublic FDA data

INTIMALE Benzocaine Delay Gel

Manufacturer
SKINS SEXUAL HEALTH LIMITED
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:05

Label at a glance#

ProductINTIMALE Benzocaine Delay Gel
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

Helps to temporarily prevent premature ejaculation.

Dosage and administration

Apply 3-5 pumps to the head and shaft of the penis before sexual activity, or as directed by your doctor. Massage the product onto the penis until fully absorbedOther Information:. You should always use the minimum effective quantity.

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 3-5 pumps to the head and shaft of the penis before sexual activity, or as directed by your doctor. Massage the product onto the penis until fully absorbedOther Information:. You should always use the minimum effective quantity.

Other Information:

SPL UNCLASSIFIED SECTION

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

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.

QUESTIONS?

OTC - QUESTIONS SECTION

You can contact us on +44 1636 593943

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle8Bottle8

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
81923-369-00INTIMALE Benzocaine Delay Gel15 mL in 1 BOTTLEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-369INTIMALE BENZOCAINE DELAY GEL (BENZOCAINE) GEL [SKINS SEXUAL HEALTH LIMITED]2Current NDC, Legacy NDC, 1 package rows20231106_b845bfd5-ab73-495f-97ef-e959bc6311d9.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
81923-36981923-369-00

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
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
ndc (package): 81923-369-00
ndc (product): 81923-369
ndc11 (package): 81923036900
spl id: 0976eff9-48b9-1669-e063-6394a90a8240
spl set id: b845bfd5-ab73-495f-97ef-e959bc6311d9

Reported adverse events (FAERS/openFDA)#

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