Active Ingredient(S)
Benzocaine.......7.5%
Calexotics Sta-hard Cream
FDA Label NDC 88055-011
10 label sections · Submitted to the FDA by California Exotic Novelties, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by California Exotic Novelties, Llc for the product Calexotics Sta-hard Cream (NDC 88055-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 the head and shaft of the 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
Purified Water, Propanediol, Ethoxydiglycol, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben
Package Label - Principal Display Panel
118 mL NDC: 77632-127-01
* Please review the disclaimer below.
