PRORINO DELAY- menthol, eucalyptus globulus, mentha arvensis cream

PRORINO DELAY by

Drug Labeling and Warnings

PRORINO DELAY by is a Homeopathic medication manufactured, distributed, or labeled by HOT PRODUCTIONS AND VERTRIEBS GMBH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 1x HPUS 

Eucalyptus Globulus Leaf Oil 0.1X HPUS

Mentha Arvenses Leaf Oil 0.05x HPUS

PURPOSE

Topical Anesthetic

USE

For temporary male genital desensitization, helping to slow 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.
Avoid contact with the eyes or broken skin.
If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
Do not use during the partner’s pregnancy.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Prior to the coitus apply a thin layer of the cream onto the glans and under it (glans frenulum) and spread by massaging.
• Approximately 5 minutes later the cream will have absorbed well and will have fully developed its effect.
• Prior to the coitus itself, the cream must be unconditionally washed off the penis and glans.
• The effect may be increased by repeated use of the cream shortly before the coitus.

OTHER INFORMATION

• Store in a cool, dry place. Protect from sunlight.

INACTIVE INGREDIENTS

Water (Aqua), Ethylhexyl Stearate, Dimethicone, Laureth-9, Pentylene Glycol, Sodium Polyacrylate, Trideceth-6, Lactic Acid, Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRORINO DELAY 
menthol, eucalyptus globulus, mentha arvensis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71326-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	.097 g  in 100 mL
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) (MENTHA ARVENSIS LEAF OIL - UNII:1AEY1M553N)	MENTHA ARVENSIS LEAF OIL	.0478 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLIDOCANOL (UNII: 0AWH8BFG9A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
LACTIC ACID (UNII: 33X04XA5AT)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71326-102-51	1 in 1 BOX	08/29/2018
1	NDC: 71326-102-11	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/29/2018

Labeler - HOT PRODUCTIONS AND VERTRIEBS GMBH (300011984)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(71326-102)