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Juvazin: Package Insert / Prescribing Info

Package insert / product label
Generic name: dimethicone
Dosage form: gel
Drug class: Miscellaneous topical agents

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

INGREDIENTS

Dimethicone, Dimethicone Crosspolymer, Trimethylsiloxysilicate.

Indications and Usage for Juvazin

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.

Juvazin 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.

image descriptionimage descriptionimage description

JUVAZIN
elastomer, silicone, for scar management
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0276-0600
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0276-0600-3030 in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceMDA12/01/2021
Labeler - Misemer Pharmaceutical (784121365)

Medical Disclaimer