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Trypsin Complex Ointment

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

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.

Trypsin Complex Ointment

FOR EXTERNAL TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
Rx Only

ACTIVE INGREDIENTS

Each gram contains Trypsin USP NLT 90 USP units, Balsam Peru 87.0 mg, Castor Oil USP 788.0 mg/g

INACTIVE INGREDIENTS

Glyceryl Monostearate, Glycine, L-Proline, Taurine and White Petrolatum.

ACTION

Balsam Peru is an effective capillary bed stimulant used to increase circulation in the wound site area. Also, Balsam Peru has a mildly bactericidal action. Castor Oil is used to promote 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 aid in the care of wound management, including decubitus ulcers, varicose ulcers and dehiscent wounds.

USES

Trypsin Complex Ointment is easy to apply and quickly reduces odor frequently accompanying a decubitus ulcer. The wound may be left open or appropriate dressing applied. As a suggestion, keep in mind wounds heal poorly in the presence of hemoglobin or zinc deficiency. Trypsin Complex Ointment can relieve pain and aid in the management of healing.

Warning

Do not apply to fresh arterial clots. Avoid contact with eyes. Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a Poison Control Center immediately. Use only as directed. When applied to a sensitive area, a temporary stinging sensation may be noted.

DOSAGE

Apply a thin film of Trypsin Complex Ointment a minimum of twice daily or as often as necessary. Wound may be left unbandaged or appropriate dressing applied. To remove, wash gently with appropriate cleanser.

How is Trypsin Complex Ointment Supplied

Trypsin Complex Ointment is supplied in 60 gram tubes. NDC 51991-124-22

Dispense in original container.

Store Trypsin Complex Ointment at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Avoid freezing.

All prescription substitutions using this product shall be pursuant to state statutes as applicable.

This is not an Orange Book product.

Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Manufactured by: Sonar Products, Inc.
Carlstadt, NJ 07072

Iss. 4/09

PRINCIPAL DISPLAY PANEL - 60 g Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-124-22

Trypsin Complex Ointment

Rx Only

Net Wt. 60 g (2.1 oz.)

TRYPSIN COMPLEX 
trypsin, balsam, peru and castor oil ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-124
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trypsin (Trypsin) Trypsin 0.0036 mg  in 1 g
Balsam, Peru (Balsam, Peru) Balsam, Peru 87.0 mg  in 1 g
Castor Oil (Castor Oil) Castor Oil 788.0 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Glyceryl Monostearate  
Glycine  
Taurine  
Petrolatum  
Product Characteristics
Color WHITE (Off-white) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-124-22 1 TUBE (TUBE) in 1 CARTON
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 10/21/2009
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 10/2009
 
Breckenridge Pharmaceutical, Inc.



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