Xtreme Ultra Thin

Approved Uses:

• Prevention of Pregnancy:
  Latex condoms serve as a mechanical barrier to prevent sperm from reaching the ovum, thereby reducing the risk of pregnancy during vaginal intercourse.
• Prevention of Sexually Transmitted Infections (STIs):
  Latex condoms significantly reduce the transmission risk of most STIs, including:
• HIV/AIDS
• Chlamydia
• Gonorrhea
• Syphilis
• Human papillomavirus (HPV)
• Herpes simplex virus (HSV)
• Trichomoniasis
• Hepatitis B and C

Off-label (Clinically Accepted) Uses:

• Protection during oral or anal sex to reduce STI transmission.
• Use with sex toys as a hygienic barrier between partners or users.
• Collection of semen for assisted reproductive techniques.

Dosage:
As a mechanical barrier, condoms are used one per sexual act. They are not reusable.

Administration Instructions:

• Use a new condom before any genital contact.
• Ensure the condom is placed on the erect penis before penetration.
• Pinch the tip to leave room for semen and unroll completely to the base.
• Withdraw the penis immediately after ejaculation while holding the base of the condom.
• Dispose of used condom in the trash—do not flush.

Special Notes:

• Do not use oil-based lubricants (e.g., petroleum jelly, baby oil) with latex condoms; they degrade latex and may cause breakage.
• Water-based or silicone-based lubricants are safe.
• For people with latex allergy, use non-latex alternatives (e.g., polyurethane or polyisoprene condoms).

Latex condoms function as physical barriers that prevent the exchange of genital secretions (semen, vaginal fluids, and blood) between sexual partners. Made from thin latex rubber, they create an impermeable layer that blocks sperm from entering the vagina and also prevent contact with mucosal tissues, thereby reducing transmission of pathogens responsible for STIs. Their effectiveness depends on correct and consistent use.

Not applicable, as condoms are non-systemic barrier devices and not absorbed or metabolized by the body.

• Pregnancy Category: Not applicable. Condoms are not pharmacologic agents.
• Lactation Safety: Safe for use during breastfeeding. No systemic exposure to the drug or device. No risk to nursing infants.

• Primary Class: Barrier Contraceptive Device
• Sub-Class: Male External Latex Condom

• Known or suspected latex allergy or sensitivity to latex materials
• Use with oil-based lubricants (for latex condoms only), which degrade latex integrity
• Use in individuals with latex-induced anaphylaxis

• Latex allergy risk: May cause mild to severe allergic reactions; individuals with sensitivity should use non-latex alternatives.
• Condom breakage or slippage: May occur with improper use, expired products, or inadequate lubrication.
• STI protection is not 100% guaranteed: Although highly effective, no condom can completely eliminate the risk of STIs.
• Storage conditions critical: Exposure to excessive heat or sunlight may degrade latex and reduce effectiveness.
• Use only once: Reuse increases risk of breakage and infection.

Local Side Effects:

• Mild irritation, itching, or redness (especially in those with latex sensitivity)
• Rarely, allergic contact dermatitis or anaphylaxis in latex-allergic individuals

Systemic Effects:
None reported with proper external use.

• Oil-based lubricants (e.g., petroleum jelly, mineral oil, body lotion):
• Effect: Break down latex, leading to tears and reduced effectiveness
• Recommendation: Use only water-based or silicone-based lubricants with latex condoms
• Topical medications (e.g., vaginal antifungals or spermicides):
• May alter condom material integrity if incompatible
• Alcohol Use:
• Does not interact with the condom, but may impair proper use due to impaired judgment or dexterity

• WHO and CDC continue to recommend consistent and correct condom use as a key preventive strategy against both unintended pregnancy and STIs including HIV.
• Updated packaging standards for condom strength, thickness, and labeling introduced by international regulatory bodies to ensure uniform quality and safety.
• Latex-free condoms increasingly recommended for populations with latex sensitivity.

• Store in a cool, dry place at 20°C to 30°C (68°F to 86°F)
• Avoid exposure to direct sunlight, humidity, and heat
• Do not store in wallets, cars, or warm pockets for long periods
• Check expiration date before use
• Do not use damaged or torn packaging