FDA.reportPublic FDA data

STAMA PRO

Manufacturer
Cerno Pharmaceuticals
Effective date
2017-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:25

Label at a glance#

ProductSTAMA PRO
Active ingredientLIDOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Each milliliter contains
 Active Ingredient Purpose
 Lidocaine Hydrochloride 9.6% Male Genital Desensitizer

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Methylparaben, Propylparaben, Carboxymethyl Cellulose Sodium, Deionized Water.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Helps in the prevention of premature ejaculation.

WARNINGS

WARNINGS SECTION

For external use only. ■ Avoid contact with the eyes.

Stop use and ask a doctor:

OTC - STOP USE SECTION

■ If you or your partner develop a rash or irritation such as burning or itching. If symptoms persist, consult a doctor.

■ 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.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Remove the protective cap. Press the actuator down repeatedly until product dispenses to prime spray pump.
Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 8 minutes before intercourse, or use as directed by a
doctor. Wash product off after intercourse. After spraying, place the cap back on.

PURPOSE

OTC - PURPOSE SECTION

Male Genital Desensitizer

Other Information

OTHER SAFETY INFORMATION

■ Keep away from fire and flames. ■ Store at 20-25°C (68-77°F)

Made in the U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70107-302-092020-01-31C16284748780-19d75b9d1-1f56-f424-e053-dadaa90a57ce19f01eb1-e9f0-447b-af94-91efc6e99aa6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70107-302-09STAMA PRO13.5 mL in 1 BOTTLE, SPRAYSPRAY13.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70107-302STAMA PRO (LIDOCAINE) SPRAY [CERNO PHARMACEUTICALS]2Legacy NDC, 1 package rows20170112_19f01eb1-e9f0-447b-af94-91efc6e99aa6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70107-30270107-302-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
WATER059QF0KO0RIACT

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
c38030a1-faaf-432d-ae2a-ab6a26e5397819f01eb1-e9f0-447b-af94-91efc6e99aa62017-01-11WarningsExact identifier
spl id: c38030a1-faaf-432d-ae2a-ab6a26e53978
spl set id: 19f01eb1-e9f0-447b-af94-91efc6e99aa6

Reported adverse events (FAERS/openFDA)#

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