Lactic Acid + Natural Plant Extract

Approved and Clinically Accepted Uses:

• Bacterial Vaginosis (BV):
  – Helps restore the natural vaginal flora and pH balance.
  – Used as adjunct therapy in the management of recurrent or mild bacterial vaginosis.
  – Supports recovery following antibiotic treatment.
• Daily Intimate Hygiene:
  – Used as a gentle cleanser to maintain acidic vaginal pH (3.5–4.5).
  – Helps reduce odor, irritation, and risk of infection without disrupting natural flora.
• Dermatological Applications (where applicable):
  – Lactic acid acts as a mild keratolytic in certain topical skin formulations.
  – Natural plant extracts (e.g., aloe vera, calendula, chamomile) provide soothing, anti-inflammatory, and moisturizing effects.

Route of Administration: Topical (vaginal or dermal depending on formulation)

For Vaginal Use (Adults):

• Dose: 2–5 mL applied intravaginally, once daily.
• Frequency: Usually at bedtime.
• Duration: Typically 7 days; may be extended as advised by a healthcare provider.

For External Intimate Hygiene:

• Dose: A small amount applied to the external genital area during washing.
• Frequency: Once daily.
• Instructions: Rinse with lukewarm water and gently pat dry.

For Dermatological Use:

• Apply a thin layer to the affected area once or twice daily.
• Avoid contact with mucous membranes unless intended for mucosal application.

Pediatric Use:

• Not recommended unless prescribed by a physician.

Elderly:

• No specific dose adjustment needed; use with caution on fragile skin.

Renal/Hepatic Impairment:

• No dosage adjustment required due to minimal systemic absorption.

Lactic acid functions by lowering the pH of the vaginal or skin environment, favoring the growth of beneficial Lactobacillus species while suppressing pathogenic bacteria. This promotes the restoration of a healthy vaginal ecosystem. Natural plant extracts, depending on their specific identity, may exert additional anti-inflammatory, antimicrobial, soothing, or antioxidant effects. Together, they enhance mucosal health, reduce irritation, and support the protective barrier function of the skin or vaginal lining.

• Absorption: Minimal systemic absorption when applied topically or intravaginally.
• Distribution: Local action only; systemic distribution is negligible.
• Metabolism:
  – Lactic acid is metabolized through normal physiological pathways (Cori cycle).
  – Plant extracts, if absorbed, are metabolized by the liver, but systemic exposure is typically minimal.
• Excretion: Trace amounts (if absorbed) are excreted renally.
• Onset of Action: Usually within 1 to 3 days of consistent use.
• Bioavailability: Not applicable due to local administration.

• Pregnancy:
  – Not assigned a formal FDA pregnancy category.
  – Generally considered safe for short-term use in pregnancy.
  – Formulations with mild concentrations of lactic acid and plant extracts are typically well tolerated.
  – Avoid products with high acid concentrations unless prescribed.
• Lactation:
  – Safe for use during breastfeeding when applied topically or intravaginally.
  – No known excretion into breast milk.
  – Avoid direct application to the breast or nipple area.

Caution:
– Choose pregnancy- and lactation-compatible products.
– Discontinue use if irritation occurs.

• Primary Class: Vaginal Acidifier / Mucosal pH Regulator
• Secondary Class (Dermal use): Alpha-Hydroxy Acid (AHA) / Soothing Skin Therapy

• Hypersensitivity to lactic acid or any plant extract in the formulation
• Open wounds, ulcers, or active irritation at the application site
• Intravaginal use during menstruation unless advised by a physician
• Use in children without medical supervision
• Use with latex condoms (some formulations may affect latex integrity)

• For external or intravaginal use only; do not ingest.
• Discontinue use if severe burning, irritation, or allergic reactions occur.
• Do not use during menstruation (vaginal formulations) unless directed.
• Avoid using with other vaginal products simultaneously unless prescribed.
• Not intended for the treatment of sexually transmitted infections.
• Consult a physician before use in cases of persistent vaginal discharge, odor, or discomfort.

Common:

• Mild vaginal or skin burning or stinging sensation
• Temporary itching or tingling
• Mild increase in vaginal discharge (indicates cleansing)

Uncommon:

• Local irritation or redness
• Dryness or peeling (especially with higher lactic acid concentrations)

Rare:

• Allergic contact dermatitis
• Severe hypersensitivity reactions
• Vaginal ulceration with overuse or misuse

Severity and Timing:

• Most reactions are mild, self-limiting, and occur shortly after application.
• Discontinue use if symptoms persist or worsen.

• Intravaginal Use:
  – Avoid concurrent use with other intravaginal medications unless instructed.
  – May weaken latex condoms or diaphragms; consider alternate contraception.
• Topical Skin Use:
  – Avoid combining with other exfoliating agents (e.g., glycolic acid, retinoids) to prevent irritation.
  – Do not use with alcohol-based products unless recommended.
• Enzyme Involvement:
  – Not associated with CYP450 metabolic pathways due to lack of systemic absorption.

• No recent safety warnings or major label changes reported by FDA, EMA, or WHO.
• Increasing use of lactic acid-based vaginal formulations for non-antibiotic maintenance of vaginal flora in women prone to recurrent infections.
• Recognized in gynecologic guidelines as supportive therapy in maintaining vaginal pH and microbiome health.

• Temperature: Store below 25°C
• Humidity: Keep in a dry place; avoid high humidity environments (e.g., bathrooms)
• Light Protection: Store in original packaging, away from direct sunlight
• Handling Precautions:
  – Do not freeze.
  – Close the cap tightly after each use.
  – Use within 30 days after opening if applicable.
• Refrigeration: Not required unless specified by the manufacturer.