PruTect by PruGen, Inc. PRUTECT-

PruTect by

Drug Labeling and Warnings

PruTect by is a Other medication manufactured, distributed, or labeled by PruGen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

PruTectTM is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions,

dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound,

PruTectTM provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external

contamination.

INDICATIONS & USAGE

PruTectTM is indicated for use in:

Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers

Superficial Wounds

1st and 2nd Degree Burns, including Sunburns

Dermal Donor and Graft Site Management

Radiation Dermatitis

Minor Abrasions

CONTRAINDICATIONS

PruTectTM is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the

ingredients is known.

WARNINGS

In radiation therapy, PruTectTM may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session.

Do not apply PruTectTM to dermal grafts until after the graft has successfully taken.

Do not apply to the eyes or to mucous membranes.

Not for internal use.

Keep out of reach of children.

PRECAUTIONS AND OBSERVATIONS

For the treatment of any dermal wound, consult a physician. Use PruTectTM only as directed.

PruTectTM is non-toxic, it is for topical use only and should not be ingested or taken internally.

PruTectTM does not contain a sunscreen and should not be used prior to extended exposure to the sun.

The use of PruTectTM on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended.

Following the application of PruTectTM a temporary tingling sensation may occur (10 to 15 minutes).

If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of PruTectTM may be

continued during the anti-infective therapy.

If condition does not improve within 10-14 days, consult a physician.

PruTectTM may dissolve fuchsin when this dye is used to dene the margins of the radiation elds to be treated.

INSTRUCTIONS FOR USE

PruTectTM is for topical use only as directed by a healthcare professional.

Wounds, Abrasions, Full Thickness Wounds, Dermal Graft Site Management and Donor Site Management

Wash the affected area(s) with saline, clean water, or a suitable wound cleanser.

Apply PruTectTM on and around the affected area(s) in thick layers 1/4 to 1/2 inch thick.

If applying gauze dressing, moisten the dressing lightly before application.

Reapply PruTectTM as described above every 24 to 48 hours or as directed until the wound or lesion has healed fully.

For donor site management, apply PruTectTM after skin removal and cover with a moist dressing. Reapply as directed.

For dermal graft site management, apply PruTectTM to the graft site only after the graft has taken successfully. PruTectTM can be

washed away with a saline solution or clean water without causing damage to the newly formed tissues.

1st and 2nd Degree Burns, Including Sunburns

Before application of PruTectTM to burns, take precaution in removing any clothing in the affected area(s).

Apply PruTectTM as soon as possible on and around the affected area(s), in a thick 1/4 to 1/2 inch layer until the skin no longer

absorbs the product. A white waxy residue may remain. If pain from the burn persists, apply thinner layers of PruTectTM until the

pain has ceased.

Continue to apply PruTectTM until the affected areas(s) has healed completely.

Application of PruTectTM to the affected area(s) should continue during any subsequent physical therapy treatments.

Radiation Dermatitis

Apply a generous amount of PruTectTM three times per day, seven days a week to the treated area(s), gently massaging the area(s)

until PruTectTM is completely absorbed.

PruTectTM may be applied as indicated by the treating physician (see WARNINGS).

Continue to apply PruTectTM as described above until the skin has fully recovered.

Do not interrupt applications during the course of radiation therapy, even for one day.

Do not apply PruTectTM 4 hours prior to a radiation session.

INGREDIENTS

PruTectTM contains purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane,

avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (potassium salt),

propylparaben (sodium salt), and fragrance.

HOW SUPPLIED

PruTectTM is supplied in a 45-gram tube (NDC: 42546-130-45) and a 90-gram tube (NDC: 42546-130-90).

Store at room temperature, do not freeze.

Rx ONLY - Prescription Medical Device: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

Manufactured for:

PruGen, Inc. Pharmaceuticals

8711 East Pinnacle Peak Road

Suite C-201 P.M.B 225

Scottsdale, AZ 85255

Rev. 1.4

PruTect Carton Label

NDC: 42546-130-45

PruTectTM

Topical Emulsion

Rx Only

45g

PruGen, Inc. Pharmaceuticals

INGREDIENTS AND APPEARANCE

PRUTECT 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:42546-130

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-130-45	1 in 1 BOX
1		45 g in 1 TUBE
2	NHRIC:42546-130-90	1 in 1 BOX
2		90 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K092878	02/01/2010

Labeler - PruGen, Inc. (929922750)