PRUTECT- dressing, wound, drug    
PruGen, Inc.

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PruTect Topical Emulsion

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

box

PRUTECT 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICE LABELItem Code (Source)NHRIC:42546-130
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:42546-130-451 in 1 BOX
145 g in 1 TUBE
2NHRIC:42546-130-901 in 1 BOX
290 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK09287802/01/2010
Labeler - PruGen, Inc. (929922750)

Revised: 8/2012
Document Id: 2270979e-cffa-487f-9f2f-e5179474c8d7
Set id: 090ceba7-5232-48db-b96b-1ed8e43ba52f
Version: 1
Effective Time: 20120822
 
PruGen, Inc.