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Granulex Spray

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

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.

GRANULEX

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

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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 
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 (CASTOR OIL) CASTOR OIL 788 mg  in 1 g
BALSAM PERU (BALSAM PERU) BALSAM PERU 87 mg  in 1 g
TRYPSIN (TRYPSIN) TRYPSIN 0.12 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:51079-621-81 56.7 g in 1 CAN
2 NDC:51079-621-82 113.4 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/27/2012
Labeler - Mylan Institutional Inc. (039615992)
Registrant - Mylan Institutional Inc. (039615992)
Establishment
Name Address ID/FEI Operations
Mylan Institutional Inc. 039615992 ANALYSIS(51079-621), MANUFACTURE(51079-621), PACK(51079-621), LABEL(51079-621)
Revised: 09/2012
 
Mylan Institutional Inc.



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