Prolayed

Manufacturer
MATRIX MIXOLOGY, INC
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:08

Label at a glance#

ProductProlayed
Active ingredientLIDOCAINE
Label structure6 sections

Dosage and administration

Apply 3 or more sprays, not to exceed 10, 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#

Active Ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 10 mg

Purpose

OTC - PURPOSE SECTION

Male genital desenitizer

Use

INDICATIONS & USAGE SECTION

Helps in temporarily slowing the onset of ejaculation.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.
  • Wash product off after intercourse.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxyethylcellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79218-001-01Prolayed1 in 1 BOXSPRAY12
79218-001-01Prolayed15 mL in 1 BOTTLESPRAY152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79218-001PROLAYED (LIDOCAINE) SPRAY [MATRIX MIXOLOGY, INC]2Current NDC, Legacy NDC, 2 package rows20231202_ae317876-adb1-6d13-e053-2995a90a74af.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79218-00179218-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact identifier
ndc (package): 79218-001-01
ndc (product): 79218-001
ndc11 (package): 79218000101
spl id: 0b6e190a-d192-f957-e063-6294a90a8cfe
spl set id: ae317876-adb1-6d13-e053-2995a90a74af

Reported adverse events (FAERS/openFDA)#

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