OTC Medication Information: Massage Men Gel Max Delay

MASSAGE MEN GEL MAX DELAY- benzocaine gel
Valley of the Sun Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Benzocaine 7%

Purpose

Male Genital Desensitizer

Uses

  • Helps in the prevention of premature ejaculation
  • Helps in temporarily prolonging the time until ejaculation

Warnings

For external use only.

When using this product

Avoid contact with the eyes.

Stop use and ask doctor

  • Premature ejacualtion 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, caffeine, sodium hydroxide

Package Label

Label
(click image for full-size original)
Outer box
(click image for full-size original)

MASSAGE MEN GEL MAX DELAY
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76523-069
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
EDETATE DISODIUM
CAFFEINE
ALCOHOL
CARBOMER 940
SODIUM HYDROXIDE
PROPANEDIOL
Product Characteristics
Color Score
Shape ROUND (Round Bottle) Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76523-069-15 15 g in 1 BOTTLE, DISPENSING None
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 Operations
Valley of the Sun Cosmetics LLC 176470664 manufacture (76523-069)

Revised: 07/2021 Valley of the Sun Cosmetics LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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