FDA.reportPublic FDA data

Juvazin

Manufacturer
Misemer Pharmaceutical
Effective date
2019-07-15
Label type
MEDICAL DEVICE
Version
6
Source
full-release
Hydrated at
2026-06-01 02:50:16

Label at a glance#

ProductJuvazin
Label structure6 sections

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.

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.

Label contents#

Full prescribing information#

INGREDIENTS

SPL UNCLASSIFIED SECTION

Dimethicone, Dimethicone Crosspolymer, Trimethylsiloxysilicate.

INDICATIONS AND USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0276-0600-30Juvazin30 in 1 TUBE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0276-0600JUVAZIN () [MISEMER PHARMACEUTICAL]61 package rows20211218_5eb73b61-c72e-4119-a749-8b905dc2f9d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0276-0600-30GM - Gram0276-060048f8831a-e972-41d9-818e-562eaa0e0d6612022-01-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0276-06000276-0600-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DIMETHICONE92RU3N3Y1OIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.