Mirvaso (Page 4 of 4)

PRINCIPAL DISPLAY PANEL 30g Pump Carton

carton-image
(click image for full-size original)

Rx Only
NDC 0299-5980-35

Mirvaso®
(brimonidine) topical gel, 0.33%*
PUMP

*Each gram of Mirvaso topical gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base

For Topical Use Only
Keep Out of Reach of Children

GALDERMA
NET WT. 30 g

Not for oral, ophthalmic or intravaginal use.
To Open Pump: Push the cap down while turning it counter-clockwise to remove the cap.
Usual Dosage: Apply a pea-size amount once daily to each of the five areas of the face (forehead, chin, nose, and each cheek) avoiding the eyes and lips. See package insert for complete prescribing information.
Each gram contains the active ingredient brimonidine tartrate 5mg with the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.

Storage: Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature].

See bottom of carton for lot number and expiration date.
All trademarks are the property of their respective owners.

Marketed by:
GALDERMA LABORATORIES, L.P.
Dallas, TX 75201 USA
Made in CanadaP52848-3

MIRVASO brimonidine tartrate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5980
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRIMONIDINE TARTRATE (BRIMONIDINE) BRIMONIDINE TARTRATE 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)
GLYCERIN
METHYLPARABEN
PHENOXYETHANOL
PROPYLENE GLYCOL
WATER
SODIUM HYDROXIDE
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5980-30 30 g in 1 TUBE None
2 NDC:0299-5980-35 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5980-35)
3 NDC:0299-5980-45 45 g in 1 TUBE None
4 NDC:0299-5980-02 2 g in 1 TUBE None
5 NDC:0299-5980-00 1 TUBE in 1 BLISTER PACK contains a TUBE
5 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5980-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204708 08/23/2013
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5980)

Revised: 12/2022 Galderma Laboratories, L.P.

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