Active Ingredient(S)
Benzocaine.......7.5%
Calexotics Optimum Rock Hard Cream
FDA Label NDC 88055-111
9 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 Optimum Rock Hard (NDC 88055-111). 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 - keep out of reach of children, directions, other information, inactive ingredients, 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
For external application only.
Stop using if you or your partner experience irritation or a rash (such as burning or itching).
Premature ejaculation can stem from underlying conditions needing medical care.
Keep out of reach of children and avoid eye contact.
Consult a physician if symptoms continue or if the product does not provide relief when used as directed.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Apply a small quantity to the head and shaft before intercourse, or follow a physician's instructions. Wash off after intercourse.
Other Information
Store between 20–25°C (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
Label (Label)
59 mL
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