INTIMALE LIDOCAINE DELAY SPRAY

Manufacturer
SKINS SEXUAL HEALTH LIMITED
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:54

Label at a glance#

ProductINTIMALE LIDOCAINE DELAY
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Helps to temporarily prevent premature ejaculation.

Dosage and administration

Apply 3 or more sprays 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 absorbed DO NOT exceed 10 sprays. You should always use the minimum effective quantity

Label contents#

Full prescribing information#

Active Ingredient (per spray):

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 10mg

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.

Do not use

OTC - DO NOT USE SECTION

• on broken or inflamed skin, if partner is pregnant, on large areas of the body, or orally.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply 3 or more sprays 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 absorbed DO NOT exceed 10 sprays. 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

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), l-Arginine, Ascorbic Acid (Vitamin C), Chamomilla Recutita (Chamomile) Extract, Epimedium (Horny Goat) Weed Extract, Ethylhexylglycerin, Folic Acid (Vitamin B9), Ginko Biloba Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethylcellulose, Hypericum Perforatum (St John’s) Extract, Lepidium Meyenii (Maca) Root Extract, Niacin, Panax Ginseng Root Extract, Phenoxyethanol, Polysorbate 20, Serenoa Serrulata (Saw Palmetto) Extract, l-Carnitine, Tocopheryl Acetate (Vitamin E), Tribulus Terrestris Extract, Zemea (Corn) Propanediol.

QUESTIONS?

OTC - QUESTIONS SECTION

You can contact us on +44 1636 593943

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle7Bottle7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
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d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
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0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
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dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81923-368-00INTIMALE LIDOCAINE DELAY15 mL in 1 BOTTLE, SPRAYSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-368INTIMALE LIDOCAINE DELAY (LIDOCAINE HYDROCHLORIDE) SOLUTION [SKINS SEXUAL HEALTH LIMITED]3Current NDC, Legacy NDC, 1 package rows20250130_5ddd7d56-bf51-462b-afcd-944861e49781.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81923-36881923-368-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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 LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
ndc (package): 81923-368-00
ndc (product): 81923-368
ndc11 (package): 81923036800
spl id: 2cc52382-513b-61e2-e063-6294a90a4fc2
spl set id: 5ddd7d56-bf51-462b-afcd-944861e49781

Reported adverse events (FAERS/openFDA)#

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