Prasterone

FDA Drug Profile — Intrarosa

Drug Details

Generic Name
Prasterone
Brand Names
Intrarosa
Application Number
NDA208470
Sponsor
Millicent US, Inc.
NDC Codes
3
Dosage Forms
INSERT, POWDER
Routes
VAGINAL
Active Ingredients
PRASTERONE

Indications and Usage

Uses: For temporary relief of minor: fatigue* stress* muscle weakness* dizziness when standing* hives* salt cravings* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

Warnings: If pregnant or breastfeeding , ask a health professional before use. Do not use if clear seal over the cap is broken or missing. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if fatigue, stress, muscle weakness, dizziness when standing, hives, salt cravings, or other symptoms do not improve within 7 days or are accompanied by fever.