PRORINO DELAY- menthol, eucalyptus globulus, mentha arvensis cream 
HOT PRODUCTIONS AND VERTRIEBS GMBH

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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HOT PRODUCTS - Prorino Delay Cream (71326-102)

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. If product is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

LBL_Prorino Delay Cream

Drug Facts_Prorino Delay Cream

PRORINO DELAY 
menthol, eucalyptus globulus, mentha arvensis cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71326-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.097 g  in 100 mL
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) (MENTHA ARVENSIS LEAF OIL - UNII:1AEY1M553N) MENTHA ARVENSIS LEAF OIL0.0478 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71326-102-511 in 1 BOX08/29/2018
1NDC:71326-102-1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/29/2018
Labeler - HOT PRODUCTIONS AND VERTRIEBS GMBH (300011984)

Revised: 10/2023
Document Id: 06fe92d8-5c82-8e4e-e063-6394a90a7414
Set id: af22b01a-1b61-4889-86c1-e4e39886236c
Version: 7
Effective Time: 20231005
 
HOT PRODUCTIONS AND VERTRIEBS GMBH