Pramoxine
/api/v1/drug/pramoxineMechanism of action
Sourced from openFDAMechanism-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 openFDADirections 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 openFDAFor 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
- 1Drug Ineffective2767.7%
- 2Off Label Use2507.0%
- 3Diarrhoea2276.3%
- 4Rash2236.2%
- 5Fatigue1915.3%
- 6Nausea1865.2%
- 7Dyspnoea1664.6%
- 8Pruritus1574.4%
- 9Dizziness1534.3%
- 10Product Quality Issue1524.2%
- 11Pain1514.2%
- 12Headache1454.0%
- 13Cough1393.9%
- 14Vomiting1153.2%
- 15Malaise1103.1%
Clinical trials
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.
- Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)Recruiting · Phase 2 · Phase 3 · Interventional · 230 enrolled · Praxis Precision MedicinesNCT06999902updated 2025-05-31
- Topical CBD's Effects on Soreness and PerformanceCompleted · Interventional · 30 enrolled · Joseph PastinaNCT06320327updated 2024-03-20
- Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer PatientsCompleted · Interventional · 53 enrolled · Johnson & Johnson Consumer Inc. (J&JCI)NCT03796052updated 2020-11-04
- Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis PatientsCompleted · Phase 4 · Interventional · 28 enrolled · Wake Forest UniversityNCT00693654updated 2018-09-10
- The Safety of Proctofoam-HC in the Third Trimester of PregnancyCompleted · Observational · 408 enrolled · The Hospital for Sick ChildrenNCT00405288updated 2014-02-05
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.
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.