Premjact Male Genital Desensitizer Spray

Manufacturer
FLEET LABORATORIES LTD
Effective date
2017-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:58

Label at a glance#

ProductPremjact Male Desensitizer Pound International
Active ingredientLIDOCAINE
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                                                        Purpose

Lidocaine Base USP 9.6% w/w (approximately 10 mg per spray)    Topical Analgesic

OTC - PURPOSE SECTION

Use temporarily reduces sensitivity of the penis, which helps to delay ejaculation in cases of over-rapid or premature ejaculation (coming to a climax too quickly

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Stop use and consult a doctor

  • if you or your partner develop a rash or irritation, such as burning or itching
  • If you do feel unwell or have any unpleasant effects after using the spray
  • if this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.
WARNINGS SECTION

Warnings

For external use only

Allergy alert: do not use this product if you or your partner are allergic (sensitive) to local anesthetics

Do not use

  • on broken or inflamed skin
  • if your partner is pregnant

Ask a doctor before use if you have, or ever had, liver or kidney problems

Ask a doctor or pharmacist before use if you are already taking prescribed drugs

When using this product

  • do not get into eyes
  • do not inhale
  • do not exceed a maximum of 24 sprays in 24 hours
DOSAGE & ADMINISTRATION SECTION

directions

  • Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse or use as directed by a doctor
  • Wash product off after intercourse
  • correct quantity and time of application will be determined by individual requirements and you should always use the minimum effective quantity
INACTIVE INGREDIENT SECTION

There are no inactive ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cancan

cartoncarton

Premjact

Male Genital Desensitizer Spray

7/16 Fl.Oz.

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70233-004-022020-01-31C16284748780-19d75b9d1-04aa-f424-e053-dadaa90a57cePremjact Male Genital Desensitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70233-004-01Premjact Male DesensitizerPound International12 mL in 1 CANSPRAY, METERED122
70233-004-02Premjact Male DesensitizerPound International1 in 1 CARTONSPRAY, METERED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70233-004PREMJACT MALE DESENSITIZER POUND INTERNATIONAL (LIDOCAINE) SPRAY, METERED [FLEET LABORATORIES LTD]2Legacy NDC, 2 package rows20170228_b907b00b-356b-458f-a9ad-d3d167f4aa4c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70233-00470233-004-01, 70233-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
STEARIC ACID4ELV7Z65APIACT

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
59a818fa-5c09-45ee-919a-afcd4d017764b907b00b-356b-458f-a9ad-d3d167f4aa4c2017-01-03WarningsExact identifier
spl id: 59a818fa-5c09-45ee-919a-afcd4d017764
spl set id: b907b00b-356b-458f-a9ad-d3d167f4aa4c

Reported adverse events (FAERS/openFDA)#

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