Premjact Male Desensitizer
FDA Label NDC 70233-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fleet Laboratories Ltd for the product Premjact Male Desensitizer (NDC 70233-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                                                        Purpose

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

Otc - Purpose

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

Keep out of reach of children

Indications & Usage

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

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

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

There are no inactive ingredients

Package Label.Principal Display Panel

Can (Can)

Can (Can)

Carton (Carton)

Carton (Carton)

Premjact

Male Genital Desensitizer Spray

7/16 Fl.Oz.

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