Trypsin Complex Ointment

Dosage Form: ointment
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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 51991-124-22 1 TUBE In 1 CARTON contains a TUBE 1 60 g In 1 TUBE This package is contained within the CARTON (51991-124-22)

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: 10/2009Breckenridge Pharmaceutical, Inc.

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