Active Ingredient
Benzocaine 7%
Massage Men Gel Max Time
FDA Label NDC 76523-068
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valley Of The Sun Cosmetics Llc for the product Massage Men Gel Max Time (NDC 76523-068). 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, purpose, uses, warning, when using this product, stop use and ask doctor, if pregnant or breast feeding, 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
Purpose
Male Genital Desensitizer
Uses
- helps in the prevention of premature ejaculation
- helps in temporarily prolonging the time until ejaculation
Warning
For external use only
When Using This Product
Avoid contact with eyes
Stop Use And Ask 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.
- If you or your partner develop rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
If Pregnant Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a poison control center right away.
Directions
- apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.
- use only on intact, non-inflamed skin
- allow gel to dry prior to intercourse
- not suitable for oral use
- use as directed, not more than four times per day
Other Information
- Store between 20-25°C (68-77°F)
- Compatible with latex condoms
- Children resistant closure. Instructions for opening are included in the leaflet
- Read the enclosed leaflet to achieve best results
Inactive Ingredients
Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, ginkgo biloba (ginkgo) extract, sodium hydroxide
* Please review the disclaimer below.
