Otc - Active Ingredient
Benzocaine - 7.5%
Prolong Plus
FDA Label NDC 69797-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wsm Investment Ll. Topco Sales for the product Prolong Plus (NDC 69797-104). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Male Genital Desensitizer
Indications & Usage
Helps in temporarily slowing 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.
- For external use only.
- Avoid contact with eyes.
- Discontinue use if you or your partner develops rash or irritation, such as burning or itching.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
- If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
Dosage & Administration
- Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor.
- Rub product into the skin of the penis until it is absorbed.
- Remove any excess to avoid any unwanted numbing before intercourse.
- Wash product off after intercourse.
Other Safety Information
- Store at room temperature 20°-25°C (68°-77°F).
- Tamper-Evident: Do not use if seal under cap is broken or missing.
Inactive Ingredient
Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.
* Please review the disclaimer below.
