pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Uses For the temporary relief of: • Pain, itching, and burning associated with minor external vaginal irritation • Minor skin irritation and discomfort in the external genital area

Dosage & administration

Sourced from openFDA

Directions For adult women 18 years and older : • Wet external vaginal area with warm water. • Dispense a small amount of wash into your hands or onto a clean washcloth. • Gently cleanse the external vaginal area only. • Allow wash to remain on skin for 30–60 seconds. • Rinse thoroughly with warm water. • Pat dry. • Use once or twice daily.

Warnings & precautions

Sourced from openFDA

For external use only. Do not use inside the vagina. Avoid contact with the eyes. If contact occurs, rinse thoroughly with water. Ask a doctor before use if you are pregnant or breastfeeding. When using this product : • Do not apply to open wounds, broken skin, or active rashes. • Do not apply more than 2 times daily. • If irritation worsens after use, discontinue immediately. • Rinse thoroughly after each use — do not leave product on skin. Stop use and ask a doctor if: • Symptoms persist for more than 7 days. • Symptoms clear up and return within a few days. • You experience unusual vaginal discharge, fever, foul odor, or pelvic pain. • Symptoms worsen at any time. • A rash or allergic reaction develops. Keep out of reach of children . If swallowed, contact a Poison Control Center immediately at 1-800-222-1222 or seek emergency medical assistance

Approval history

Sourced from openFDA
  • Jan 7, 1977ANDAANDA085368Legacy Pharma
  • Jun 5, 1978ANDAANDA085979Legacy Pharma
  • Jun 5, 1978ANDAANDA085980Legacy Pharma
  • Jul 26, 1978ANDAANDA086195Mylan Speciality Lp
  • Dec 19, 1979ANDAANDA086457Mylan Speciality Lp

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,582 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective2767.7%
  2. 2Off Label Use2507.0%
  3. 3Diarrhoea2276.3%
  4. 4Rash2236.2%
  5. 5Fatigue1915.3%
  6. 6Nausea1865.2%
  7. 7Dyspnoea1664.6%
  8. 8Pruritus1574.4%
  9. 9Dizziness1534.3%
  10. 10Product Quality Issue1524.2%
  11. 11Pain1514.2%
  12. 12Headache1454.0%
  13. 13Cough1393.9%
  14. 14Vomiting1153.2%
  15. 15Malaise1103.1%

Clinical trials

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The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Pramoxine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pramoxine work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Pramoxine used for?
According to FDA labeling, Pramoxine carries indications including: Uses For the temporary relief of: • Pain, itching, and burning associated with minor external vaginal irritation • Minor skin irritation and discomfort in the external genital area. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pramoxine?
Pramoxine is classified as Anesthetics for topical use, Local anesthetics, Unknown Cellular or Molecular Interaction, Decreased Sensory-Somatic Nervous System Organized Electrical Activity.
What are the brand names for Pramoxine?
Pramoxine is marketed under brand names including AmLactin AP, Analpram HC, Calaclear, Caladryl, Caladryl Clear, Calagesic, Callergy Clear, Cortane-B.
Note. Data for pramoxine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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