HOT PRODUCTS - Prorino Delay Spray (71326-202)

Manufacturer
HOT PRODUCTIONS AND VERTRIEBS GMBH
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:22:29

Label at a glance#

ProductPRORINO DELAY
Active ingredientMENTHOL, EUCALYPTUS OIL, MENTHA ARVENSIS LEAF OIL
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5x HPUS

Eucalyptus Globulus Leaf Oil 0.1x HPUS

Mentha Arvenes Leaf Oil 0.1x HPUS

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

USE

INDICATIONS & USAGE SECTION

For temporary male genital desensitization, helping to slow the onset of ejaculation.

WARNINGS

WARNINGS SECTION

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 SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBL_Prorino Delay SprayLBL_Prorino Delay Spray

Drug Facts_Prorino Delay SprayDrug Facts_Prorino Delay Spray

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71326-202-512024-07-30C16284748780-11030e365-1ae7-111a-e063-dadaa90a10e2HOT PRODUCTS - Prorino Delay Spray (71326-202)
71326-202-512024-01-30C16284748780-11030e365-1ae7-111a-e063-dadaa90a10e2HOT PRODUCTS - Prorino Delay Spray (71326-202)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71326-202-11PRORINO DELAY15 mL in 1 BOTTLE, SPRAYSPRAY157
71326-202-51PRORINO DELAY1 in 1 BOXSPRAY17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71326-202PRORINO DELAY (MENTHOL, EUCALYPTUS GLOBULUS, MENTHA ARVENSIS) SPRAY [HOT PRODUCTIONS AND VERTRIEBS GMBH]7Legacy NDC, 2 package rows20231006_064a6fb2-edfa-4bb8-946d-3d7eb5db3ec8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71326-20271326-202-11, 71326-202-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
06fe77f7-a202-f066-e063-6294a90a7653064a6fb2-edfa-4bb8-946d-3d7eb5db3ec82023-10-05WarningsExact identifier
spl id: 06fe77f7-a202-f066-e063-6294a90a7653
spl set id: 064a6fb2-edfa-4bb8-946d-3d7eb5db3ec8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.