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Optase Wound Care Gel

Generic Name: trypsin, castor oil and balsam peru
Dosage Form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


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.

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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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:16781-116-95 95 g in 1.0 BOTTLE
2 NDC:16781-116-06 10 TUBE (10 TUBE) in 1 BOX
2 6 g in 1.0 TUBE
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: 12/2011
 
Onset Dermatologics LLC



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