MASSAGE MEN GEL MAX POWER- benzocaine gel

Massage Men Gel Max Power by

Drug Labeling and Warnings

Massage Men Gel Max Power by is a Otc medication manufactured, distributed, or labeled by Valley of the Sun Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 5%

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 the eyes.

Stop use and ask doctor

• Premature ejaculation may be due to a condition requiring medical supervion. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
• If you or your partner develop a 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 resistent 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, wthania somnifera (ashwagandha) root extract, sodium hydroxide

Package Label

INGREDIENTS AND APPEARANCE

MASSAGE MEN GEL MAX POWER 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76523-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape	ROUND (Round Bottle)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76523-062-15	15 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/01/2021

Labeler - Valley of the Sun Cosmetics LLC (176470664)

Registrant - Valley of the Sun Cosmetics LLC (176470664)

Establishment
Name	Address	ID/FEI	Business Operations
Valley of the Sun Cosmetics LLC		176470664	manufacture(76523-062)