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 Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-116
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRYPSIN (Trypsin) TRYPSIN 0.12 g  in 100 g
CASTOR OIL (CASTOR OIL) CASTOR OIL 78.77 g  in 100 g
BALSAM, PERU (BALSAM, PERU) BALSAM, PERU 8.69 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE 3.08 g  in 100 g
SAFFLOWER OIL 7.31 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16781-116-95 95 g In 1 BOTTLE None
2 16781-116-06 10 TUBE In 1 BOX contains a TUBE
2 6 g In 1 TUBE This package is contained within the BOX (16781-116-06)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 04/01/2006

Labeler - Onset Therapeutics, LLC (793223707)
Registrant - Collegium Pharmaceutical, Inc. (032531241)
Establishment
Name Address ID/FEI Operations
Onset Therapeutics, LLC 793223707 RELABEL
Establishment
Name Address ID/FEI Operations
Collegium Pharmaceutical, Inc. 001207208 MANUFACTURE
Revised: 07/2009 Onset Therapeutics, LLC