JO PROLONGER WITH BENZOCAINE- benzocaine spray

JO Prolonger with Benzocaine by

Drug Labeling and Warnings

JO Prolonger with Benzocaine by is a Otc medication manufactured, distributed, or labeled by CC Wellness LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 7.5%

PURPOSE

Male Genital Desensitizer

INDICATIONS & USAGE

For temporary male genital desensitization

Helps to slow the onset of ejaculation

Compatible with natural rubber latex and polyisoprene condoms

For external use only

Avoid Contact with the eyes

Allergy alert: do not use this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients

Do not use on broken or inflamed skin

Ask a doctor before use

If your partner is pregnant

If you have or have had liver or kidney problems

Ask a doctor or pharmacist before use if you are already taking prescribed drugs

When using this product

• Do not get into eyes or nostrils
• Do not inhale
• Do not exceed a maximum of 20 sprays in 24 hours
• Always use the minimum amount effective for you
• Allow 5-15 minutes to dry prior to intercourse

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 a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Can be used for sexcual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.

Keep out of reach of children

Directions:

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor.

Wash product off after intercourse.

Other information:

Do not expose to heat or flame.

Store at 20-30°C (68-77°F)

Inactive ingredients:

PEG-8, Propylene Glycol, Water (Aqua)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JO PROLONGER WITH BENZOCAINE 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71683-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71683-004-01	1 in 1 BOX	09/03/2015
1	NDC: 71683-004-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	09/03/2015

Labeler - CC Wellness LLC (067692292)

Establishment
Name	Address	ID/FEI	Business Operations
CC Wellness LLC		067692292	manufacture(71683-004)