NDC 71326-202 Prorino Delay

Menthol, Eucalyptus Globulus, Mentha Arvensis

NDC Product Code 71326-202

NDC 71326-202-51

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 15 mL in 1 BOTTLE, SPRAY (71326-202-11)

NDC Product Information

Prorino Delay with NDC 71326-202 is a a human over the counter drug product labeled by Hot Productions And Vertriebs Gmbh. The generic name of Prorino Delay is menthol, eucalyptus globulus, mentha arvensis. The product's dosage form is spray and is administered via topical form.

Labeler Name: Hot Productions And Vertriebs Gmbh

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prorino Delay Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL .5 g/100mL
  • EUCALYPTUS OIL .1 g/100mL
  • MENTHA ARVENSIS LEAF OIL .1 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLIDOCANOL (UNII: 0AWH8BFG9A)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+)- (UNII: F4VNO44C09)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hot Productions And Vertriebs Gmbh
Labeler Code: 71326
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-29-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Prorino Delay Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Menthol 0.5x HPUSEucalyptus Globulus Leaf Oil 0.1x HPUSMentha Arvenes Leaf Oil 0.1x 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.

Otc - 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

Alcohol Denat., Water (Aqua), Glycerin, Laureth-9, Panthenol, Lactic Acid, Limonene, Linalool

* Please review the disclaimer below.