FDA Label for Optimum Rock Hard Cream
View Indications, Usage & Precautions
Optimum Rock Hard Cream Product Label
The following document was submitted to the FDA by the labeler of this product Private Label Productions Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Benzocaine.......7.5%
Purpose
Male Genital Desensitizer
Use
Helps in prevention of premature ejaculation
Warnings
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
Do Not Use « For teething @ In children under 2 years of age
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
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
Store at 20-25°C ( equals 68-77°F)
Inactive Ingredients
Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propanediol, Propylene Glycol, Propylparaben, Triethanolamine, Water (Aqua)
Package Label - Principal Display Panel
59 mL NDC: 77632-126-01
* Please review the disclaimer below.