Active Ingredient(S)
Lidocaine 10% Male Genital Desensitizer
Spartan Spray
FDA Label NDC 84930-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tiv Prime Srl for the product Spartan (NDC 84930-112). 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, inactive ingredients, other safety 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 temporarily delay ejaculation.
Warnings
For external use only
Do not use
• if you or your partner are allergic to lidocaine or to
other topical anesthetics
When using this product
• avoid contact with eyes
• do not spray on broken, irritated, or sensitive skin
Stop use and ask a doctor if
• This product, used as directed, does not provide relief.
Premature ejaculation may be due to a condition requiring
medical supervision
• you or your partner develops a rash, irritation, or burning,
or itching
Ask a doctor or pharmacist before use if
liver disease
• a partner who is pregnant or may be pregnant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Shake gently before use
• Hold upright and press the pump to dispense the spray
• Apply 2-5 sprays to the head and shaft of the penis
5 minutes before intercourse, or use as directed by a doctor
• do not use more than 10 times in 24 hours
• wash product off after intercourse
Inactive Ingredients
Ethyl alcohol (SDA 408), propylene glycol, purified water.
Other Safety Information
store at 68-770F (20-250C)
Package Label - Principal Display Panel
Label (Label)
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