SKINS Bubblegum

Approved Indications:

• Contraception:
  Latex Condom [SKINS] is indicated for the prevention of pregnancy by acting as a physical barrier that blocks sperm from entering the female reproductive tract during vaginal intercourse.
• Sexually Transmitted Infection (STI) Prevention:
  Reduces the risk of transmission of STIs, including:
• Human Immunodeficiency Virus (HIV)
• Gonorrhea
• Syphilis
• Chlamydia
• Herpes Simplex Virus (HSV)
• Human Papillomavirus (HPV)
• Hepatitis B and C

Clinically Accepted Uses:

• Sexual Health Education:
  Used in clinical, school, and public health settings for demonstrating safe sex practices.
• Postpartum or Postabortion Use:
  Suitable as a temporary contraceptive during postpartum recovery or post-procedure intervals when hormonal methods are contraindicated.

Dosage:

• One condom per sexual act. Do not reuse.

Route of Administration:

• External application on an erect penis.

Instructions for Use:

1.        Open the foil package carefully to avoid damaging the condom.

2.        Pinch the reservoir tip and roll the condom down the full length of the erect penis.

3.        After ejaculation, hold the base of the condom while withdrawing to avoid leakage or slippage.

4.        Dispose of properly. Do not reuse or flush.

Special Populations:

• Safe for use in all sexually active individuals regardless of age.
• Not affected by hepatic, renal, or other systemic conditions.
• Individuals with latex allergy should use non-latex alternatives (e.g., polyurethane, polyisoprene).

Latex Condom [SKINS] functions as a mechanical barrier that physically prevents the exchange of semen, vaginal fluids, and blood between sexual partners. This effectively blocks sperm from reaching the ovum, thereby preventing fertilization. Simultaneously, it minimizes direct mucosal contact and fluid exchange, reducing the transmission risk of STIs including viruses and bacteria. Its effectiveness depends on correct and consistent use.

Not applicable.
Latex condoms are external, non-systemic devices. They are not absorbed into the body, do not distribute through tissues, are not metabolized, and are not excreted. Therefore, they have no pharmacokinetic properties.

Pregnancy:

• FDA Category N (Not assigned): No systemic exposure occurs. Latex condoms are safe for use before, during, and after pregnancy.

Lactation:

• Safe during breastfeeding. No systemic absorption or excretion into breast milk occurs. Does not affect milk production or infant safety.

• Primary Therapeutic Class: Mechanical Barrier Contraceptive
• Subcategory: Male Latex Condom
• Purpose: Dual protection for contraception and STI prevention

• Known hypersensitivity to natural rubber latex
• History of latex-induced anaphylaxis or allergic reactions
• Do not use if the condom is damaged, discolored, expired, or improperly stored

• Latex Allergy Risk: May cause allergic reactions including localized itching, rash, or systemic anaphylaxis in sensitive individuals.
• Lubricant Compatibility:
• Compatible: Water-based or silicone-based lubricants
• Incompatible: Oil-based products (e.g., petroleum jelly, baby oil), which weaken latex and increase breakage risk
• Use Only Once: Single-use only. Reuse significantly increases the failure rate.
• Check Expiry Date & Packaging: Compromised packaging or expired products should not be used.
• Proper Storage Required: Heat, light, and humidity can degrade latex integrity.

Common:

• Mild genital irritation or discomfort
• Friction-related sensations

Less Common:

• Localized rash or contact dermatitis
• Latex sensitivity symptoms (itching, redness)

Rare but Serious:

• Severe allergic reactions (e.g., generalized urticaria, anaphylaxis)

Onset & Severity:
Most reactions are immediate and resolve quickly after discontinuation. Severe allergic reactions require urgent medical attention.

Not applicable.
No interactions with drugs, food, or alcohol due to non-systemic use.

Material Interactions:

• Incompatible with oil-based substances which degrade latex.
• Only use with water-based or silicone-based lubricants to maintain effectiveness.

• WHO & CDC Recommendations: Condoms remain a first-line barrier method for reducing transmission of HIV and other STIs.
• ISO 4074 Standard: Latex Condom [SKINS] must comply with international safety and durability standards, including tensile strength, burst resistance, and leak testing.
• Public Health Focus: Continued emphasis on education regarding proper storage, use, and disposal, particularly in youth and high-risk groups.

• Temperature: Store at 20°C to 30°C
• Light & Humidity Protection: Keep in a cool, dry place away from direct sunlight and excessive moisture
• Handling:
• Do not store in wallets, glove compartments, or areas exposed to friction and heat
• Inspect before use; discard if damaged
• Shelf Life: Typically 3 to 5 years, depending on brand and packaging
• Disposal: Wrap in tissue or packaging and dispose of in the trash. Do not flush.