Juvazin by Misemer Pharmaceutical JUVAZIN-

Juvazin by

Drug Labeling and Warnings

Juvazin by is a Other medication manufactured, distributed, or labeled by Misemer Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INGREDIENTS

Dimethicone, Dimethicone Crosspolymer, Trimethylsiloxysilicate.

INDICATIONS AND USES

JuvazinTM is intended for the management of old and new scars, including hypertrophic and keloid scars, resulting from general surgical procedures, trauma, wounds and burns.

WARNINGS

Avoid direct contact with eyes, mucous membranes, third degree burns and open
wounds. JuvazinTM should not be used on dermatological conditions that disrupt the
integrity of the skin. For external use only. If irritation occurs, discontinue use and
consult your physician.
Keep this product out of the reach of children.
Store below 25°C/77°F.

PRECAUTIONS

Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
Call your doctor about side effects. You may report side effects to the FDA
at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION

Ensure that the affected area is clean and dry. Apply JuvazinTM to the area as a very
thin coat and allow to dry. Apply JuvazinTM twice daily. Once dry, JuvazinTM can be
covered with cosmetics or sunscreen. Recommended duration of treatment 60-90
days.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUVAZIN 
elastomer, silicone, for scar management

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0276-0600

Inactive Ingredients
Ingredient Name	Strength
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0276-0600-30	30 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	MDA	12/01/2021

Labeler - Misemer Pharmaceutical (784121365)