Skin redness and flushing may happen about 3 to 4 hours after you apply MIRVASO topical gel. Tell your doctor if you get skin redness and flushing that is uncomfortable for you.
MIRVASO topical gel can lower blood pressure in people with certain heart or blood vessel problems. See “What should I tell my doctor before using MIRVASO topical gel?”
These are not all the possible side effects of MIRVASO topical gel.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of MIRVASO topical gel
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. You can ask your pharmacist or doctor for information about MIRVASO topical gel that is written for health professionals. Do not use MIRVASO topical gel for a condition for which it was not prescribed. Do not give MIRVASO topical gel to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in MIRVASO topical gel?
Active Ingredient: brimonidine tartrate
Inactive Ingredients: carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, titanium dioxide.
Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177 USA
Made in Canada.
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: August 2013
Instructions for Use
MIRVASO (Mer-VAY-soe)
(brimonidine) Topical Gel
Important: MIRVASO® topical gel is for use on the face only. Do not use MIRVASO topical gel in your eyes, mouth, or vagina.
Keep MIRVASO topical gel out of the reach of children.
If anyone, especially a child, accidentally swallows MIRVASO topical gel, they may have serious side effects and need to be treated in a hospital. Get medical help right away if you, a child, or anyone else swallows MIRVASO topical gel and has any of these symptoms:
• lack of energy, trouble breathing or stops breathing, a slow heart beat, confusion, sweating, restlessness, muscle spasms, or twitching.
Read and follow the steps below so that you use MIRVASO topical gel correctly:
1. Open the tube of MIRVASO topical gel by gently pressing down on the child resistant cap and twist in the direction of the arrow as shown below, a quarter of a turn (counterclockwise). See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.
Figure A
Figure B
2. To apply MIRVASO topical gel to your face, squeeze a pea-sized amount of MIRVASO topical gel from the tube onto your fingertip. See Figure C.
Figure C
3. Apply a pea-sized amount of MIRVASO topical gel onto each of the five areas of your face (forehead, chin, nose, each cheek) 1 time each day. You will use a total of 5 pea-sized amounts of MIRVASO topical gel. Spread the gel smoothly and evenly in a thin layer over your face. Avoid contact with your eyes and lips. Do not apply MIRVASO topical gel to irritated skin or open wounds.
4. To close MIRVASO topical gel, line up the grooves on the cap and the tube. Gently press down on the child resistant cap and twist to the right, a quarter of a turn (clockwise). See Figures D and E.
Figure D
