PROLONG PLUS- benzocaine cream

Prolong Plus by

Drug Labeling and Warnings

Prolong Plus by is a Otc medication manufactured, distributed, or labeled by WSM Investment LL. Topco Sales, WSM Investment LLC. Topco Sales. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine - 7.5%

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROLONG PLUS 
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69797-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	4.2 g  in 56 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
AMERICAN GINSENG (UNII: 8W75VCV53Q)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69797-104-01	56 g in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	12/19/2017

Labeler - WSM Investment LL. Topco Sales (040346439)

Establishment
Name	Address	ID/FEI	Business Operations
WSM Investment LLC. Topco Sales		040346439	manufacture(69797-104)