Prolayed Spray
FDA Label NDC 79218-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Matrix Mixology, Inc for the product Prolayed (NDC 79218-001). 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 drug facts, active ingredient (in each spray), purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Spray)

Lidocaine 10 mg

Purpose

Male genital desenitizer

Use

Helps in temporarily slowing the onset of ejaculation.

Warnings

For external use only

When Using This Product

  • avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

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:

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