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Granulex Spray Prescribing Information

Package insert / product label
Generic name: castor oil, balsam peru and trypsin
Dosage form: topical spray
Drug class: Topical debriding agents

Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.

NDC 51079-621-81

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)

Rx only

Mylan.com

Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Net Wt.
2 oz. (56.7g)

Indications and Usage for Granulex Spray

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.

Warnings

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.

301.3
Contents: Net weight 2 oz. (56.7g)
Inert propellant 25% of total content.

PRINCIPAL DISPLAY PANEL

NDC 51079-621-81

GRANULEX

Granulex 2 oz. Label
GRANULEX
trypsin, balsam peru and castor oil spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51079-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL788 mg in 1 g
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU87 mg in 1 g
TRYPSIN, UNSPECIFIED FORM (UNII: GV54A213NN) (TRYPSIN, UNSPECIFIED FORM - UNII:GV54A213NN) TRYPSIN, UNSPECIFIED FORM0.12 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-621-8156.7 g in 1 CAN; Type 0: Not a Combination Product03/01/196705/31/2018
2NDC:51079-621-82113.4 g in 1 CAN; Type 0: Not a Combination Product03/01/196705/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/01/196705/31/2018
Labeler - Mylan Institutional Inc. (039615992)

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