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Granulex

Mylan Institutional Inc.
Mylan Institutional Inc.

GRANULEX


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SHAKE WELL BEFORE EACH USAGE
Hold Upright to Spray

The nozzle of the canister is designed for large
volume delivery of medication, therefore, proper
coverage of the wound site is achieved quickly.

PHYSIOLOGICAL DEBRIDEMENT
CAPILLARY BED STIMULANT
PROMOTES GRANULATION

Each gram contains:
     Trypsin, USP.........................0.12 mg
     Balsam Peru..........................87.0 mg
     Castor Oil, USP...................788.0 mg
       With an emulsifier and propellants
                 (Water Dispersible)

UDL Laboratories, Inc.
Rockford, IL 61103
Rx only
2 oz.
Net Wt.
(56.7g)

UDL Laboratories, Inc.
Rockford, IL 61103
Rx only
4 oz.
Net Wt.
(113. 4g)

INDICATIONS

Varicose Ulcers        Debride Eschar        Dehiscent Wounds
Decubital Ulcers       Sunburn                   Wound Healing

GRANULEX will relieve pain and promote healing; debrides
eschar and necrotic tissue physiologically; stimulates
vascular bed; improves epithelization by reducing
premature epithelial desiccation and cornification; reduces
odor from malodorous necrotic wounds.

DIRECTIONS

Shake well before spraying. Hold upright
and approximately 12 inches from the area to be treated.
Press valve and coat wound rapidly. Wound may be left
unbandaged or apply a wet dressing. Apply twice daily or
as often as necessary. To remove, wash gently with water.
When applied to a sensitive area, a temporary stinging
sensation may be noted.

WARNING

Do not use on fresh arterial clots. Avoid
spraying in eyes. Flammable, do not expose to fire or open
flame. Contents under pressure. Do not puncture or
incinerate. Do not store at temperature above 120°F. Keep
out of reach of children. Use only as directed. Intentional
misuse by deliberately concentrating and inhaling the
contents can be harmful or fatal.

 301.2
Contents: Net weight 2 oz. (56.7g)
Inert propellant 25% of total content.

302.2
Contents: Net weight 4 oz. (113.4g)
Inert propellant 25% of total content.

PRINCIPAL DISPLAY PANEL

NDC No. 51079-621-81

GRANULEX

Granulex

Granulex

trypsin, balsam peru and castor oil SPRAY

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51079-621
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
castor oil 788 mg
BALSAM PERU 87 mg
TRYPSIN TRYPSIN 0.12 mg

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51079-621-81 56.7 in 1 CAN
2 NDC:51079-621-82 113.4 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-09-27


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