Prorino Delay
FDA Label NDC 71326-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hot Productions And Vertriebs Gmbh for the product Prorino Delay (NDC 71326-202). 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 active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 0.5x HPUS

Eucalyptus Globulus Leaf Oil 0.1x HPUS

Mentha Arvenes Leaf Oil 0.1x HPUS

Purpose

Topical Anesthetic

Use

For temporary male genital desensitization, helping to slow the onset of ejaculation.

Warnings

Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
Avoid contact with the eyes or broken skin.
If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
Do not use during the partner’s pregnancy.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Prior to the coitus apply a thin layer of the cream onto the glans and under it (glans frenulum) and spread by massaging.
  • Approximately 5 minutes later the cream will have absorbed well and will have fully developed its effect.
  • Prior to the coitus itself, the cream must be unconditionally washed off the penis and glans.
  • The effect may be increased by repeated use of the cream shortly before the coitus.

Other Information

  • Store in a cool, dry place. Protect from sunlight.

Inactive Ingredients

Alcohol Denat., Water (Aqua), Glycerin, Laureth-9, Panthenol, Lactic Acid, Limonene, Linalool

Package Label.Principal Display Panel

* Please review the disclaimer below.