Optase Wound Care Gel

trypsin, castor oil and balsam peru

Dosage Form: gel


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

NDC 16781-116-95

Rx Only

WOUND CARE GEL


Optase™


FOR EXTERNAL USE ONLY


NET WT. 95g PATENT PENDING

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Optase 10 Tube Label

NDC 16781-116-06

Rx Only

Net Wt. 6g

WOUND CARE GEL


Optase®

Trypsin USP, Balsam Peru, Castor Oil USP

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 0.012 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   SAFFLOWER OIL

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 drug other		04/01/2006	12/31/2011

Labeler - Onset Dermatologics LLC (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Onset Dermatologics LLC		793223707	Manufacture

Revised: 12/2011Onset Dermatologics LLC

More Optase Wound Care Gel resources

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