Promescent Spray
FDA Label NDC 55636-590

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Absorption for the product Promescent (NDC 55636-590). 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 ingredient (per spray), purpose, keep out of reach of children, use:, warnings:, directions:, inactive ingredients:, labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Spray)

Lidocaine approx. 10mg

Purpose

Anesthetic

Keep Out Of Reach Of Children

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

Use:

Helps in temporarily slowing the onset of ejaculation.

Warnings:

​For external use only.​

​Do not use if​

  • You or your partner are allergic to lidocaine or topical anesthetics.
  • Your partner is, or may be pregnant.

    • ​Ask a doctor or pharmacist before use if​

    • You have liver problems.

      • ​When using this product​

      • Do not spray on broken, irritated or sensitive skin.
      • Avoid contact with the eyes.

        • ​Stop use and ask a doctor

        • If you or your partner develop a rash or irritation, such as burning or itching, dicontinue use. If symptoms persist, consult a doctor.
        • 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. ​​

Directions:

Break front tab first. To unlock, press in special Child Resistant (R) tab in back of the actuator while turning the actuator to the right. Press the actuator down repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse, or use as directed by a doctor. Recommended Initial Dosage: 3 sprays. Rub Promescent into the skin of the penis until all of the product is absorbed. Wash product off after intersourse. After spraying, turn actuator to the left to lock.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Dimethicone, Farnesol, Fragrance, Glycerin, Hydrogenated Polyisobutene, Macadamia Ternifolia Seed Oil, Panthenol, Phenoxyethanol, Purified Water (Aqua), SD Alcohol 40-B, Sodium Hydroxide, Soy Lecithin, Stearoxytrimethylsilane, Stearyl Alcohol, Thymol, Tocopheryl Acetate (Vitamin E).

Labeling

Label (Label)

Label (Label)

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