Optase WOUND CARE GEL

OPTASE - trypsin, castor oil and balsam, peru gel 
Onset Therapeutics, LLC

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Optase
WOUND CARE GEL

DESCRIPTION:

Balsam Peru is an effective capillary bed stimulant used to increase circulation in the wound area. Also, Balsam Peru has a mild bactericidal action. Castor Oil is used to improve epithelialization by reducing premature epithelial desiccation and cornification. Also, it can act as a protective covering and aids in the reduction of pain. Trypsin is intended for debridement of eschar and other necrotic tissue. It appears that in many instances removal of wound debris strengthens humoral defense mechanisms sufficiently to retard proliferation of local pathogens.

INDICATIONS:

To promote healing and the treatment of decubitus ulcers, varicose ulcers and dehiscent wounds.

WARNING:

Do not apply to fresh arterial clots. Avoid contact with eyes. Keep out of reach of children. Use only as directed. When applied to a sensitive area, a temporary stinging sensation may be noted.

DOSAGE:

Remove Safety Seal under cap. Apply a thin film of OPTASETM Gel a minimum of twice daily or as often as necessary. The wound may be left unbandaged or appropriate dressing applied. To remove, wash gently with appropriate cleanser.

HOW SUPPLIED:

OPTASETM Gel is supplied in 95g bottles (NDC# 16781-116-95) and 6g tubes (NDC# 16781-116-06). Store OPTASETM Gel between 59-86ºF (15-30ºC). Avoid freezing.

FOR EXTERNAL USE ONLY

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Optase Bottle Front Label

Optase Front Label


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Optase  Bottle Back Label


Optase Back Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Optase Box of 10 Tubes

NDC 16781-116-06

Rx Only

10 x 6g tubes

WOUND CARE GEL


Package Label-Optase 10 Tube Box


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Optase 10 Tube Label

NDC 16781-116-06

Rx Only

10 x 6g tubes

WOUND CARE GEL

Package Label-Optase Tube Label


OPTASE 
trypsin,castor oil,balsam, peru   gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)16781-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRYPSIN (Trypsin) TRYPSIN0.12 g  in 100 g
CASTOR OIL (CASTOR OIL) CASTOR OIL78.77 g  in 100 g
BALSAM, PERU (BALSAM, PERU) BALSAM, PERU8.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE3.08 g  in 100 g
SAFFLOWER OIL7.31 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
116781-116-9595 g In 1 BOTTLENone
216781-116-0610 TUBE In 1 BOXcontains a TUBE
26 g In 1 TUBEThis package is contained within the BOX (16781-116-06)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other04/01/2006

Labeler - Onset Therapeutics, LLC (793223707)
Registrant - Collegium Pharmaceutical, Inc. (032531241)
Establishment
NameAddressID/FEIOperations
Onset Therapeutics, LLC793223707RELABEL
Establishment
NameAddressID/FEIOperations
Collegium Pharmaceutical, Inc.001207208MANUFACTURE
Revised: 07/2009Onset Therapeutics, LLC