Optimum Rock Hard Cream

Manufacturer
Private Label Productions LLC
Effective date
2023-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:29:02

Label at a glance#

ProductOptimum Rock Hard Cream
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor. Wash product off after intercourse. Children under 2 years of age: Do not use.

Storage and handling

Store at 20-25°C ( equals 68-77°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine.......7.5%

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Use

INDICATIONS & USAGE SECTION

Helps in prevention of premature ejaculation

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause
methemoglobinemia, a serious condition that must be treated promptly
because it reduces the amount of oxygen carried in blood. This can occur
even if you have use this product before. Stop use and seek immediate
medical attention if you or a child in your care develops: ¢ pale, gray, or
blue colored skin (cyanosis) * headache e rapid heart rate ¢ shortness
of breath e dizziness or lightheadedness e fatigue or lack of energy
Allergy alert: Do not use this product if you have a history of allergy to
local anesthetics such as procaine, butacaine, benzocaine or any other
‘caine’ anesthetics.

For external use only. Avoid contact with eyes. If you or your partner
develop a rash or irritation such as burning or itching discontinue use.
Premature ejaculation may be due to a condition requiring medical
supervision. Keep out of reach of children. If symptoms persist consult a
physician. If this product, used as directed, does not provide relief,
discontinue use and consult a doctor.

OTC - DO NOT USE SECTION

Do Not Use « For teething @ In children under 2 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor. Wash product off after intercourse. Children under 2 years of age: Do not use.

Other information

STORAGE AND HANDLING SECTION

Store at 20-25°C ( equals 68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propanediol, Propylene Glycol, Propylparaben, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label numbing 59mLlabel numbing 59mL59 mL NDC: 77632-126-01

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77632-12677632-126-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
fff2c971-2fe4-1f6e-e053-6394a90a90c4fff2c946-f4c8-5633-e053-6294a90aace42023-07-08WarningsExact identifier
spl id: fff2c971-2fe4-1f6e-e053-6394a90a90c4
spl set id: fff2c946-f4c8-5633-e053-6294a90aace4

Reported adverse events (FAERS/openFDA)#

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