9?8. /6 ' · # " &9?8. /6 ' 0 ! % 3->9

Prontosan® Wound Gel X

For maintaining a clean andmoist wound environment thatis conducive to healing

P-8265-2 REV. 9/1787316

1 2 3

Pictorials are for reference only.

LOT REF

See instructionsfor use.

2For single patient use only.Do not resterilize.

Rx only

Expiration Date Lot Number Reorder Number

Not made with naturalrubber latex or DEHP.

STERILE by steam sterilization, until theproduct is first opened.NONPYROGENICfluid and fluid path prior to removal of cap.

Description:Prontosan Wound Gel Xis a clear, colorless, andvirtually odorlessaqueous amorphoushydrogel wounddressing.

Prontosan Wound Gel Xcontains: 0.1% PolyaminopropylBiguanide(Polyhexanide [PHMB]),AlkylamidopropylBetaine, Purified Water,Hydroxyethylcellulose,and Glycerol.

PHMB is added to theproduct as apreservative to inhibitthe growth ofmicroorganisms withinthe product.

Indications:Prontosan Wound Gel Xis indicated for themanagement of ulcers(including diabetic footand leg ulcers andpressure ulcers), firstand second degreeburns, partial and fullthickness wounds,large surface areawounds, and surgicalincisions.

Prontosan Wound Gel X• is an effectivemicrobial barrier

• resists microbialcolonization withinthe dressing

• reduces microbialpenetration throughthe dressing

• softens necrotictissue facilitatingautolyticdebridement

Adverse Reactions:In very rare cases, theremay be a mild burningsensation afterapplication whichsubsides after a fewminutes. Prontosan cancause allergic reactionssuch as itching andrashes. In rare cases(less than 1 out of10,000), anaphylacticshock has beenreported withProntosan products.

Contraindications:• Prontosan Wound Gel Xshould not be used ifthere is a history ofallergy to any of theingredients.

• Do not use in thepresence of hyalinecartilage.

• Do not use incombination withanionic surfactantsas these may impairpreservation.

• Mixing ProntosanWound Gel X withother woundcleansing soaps,lotions, ointments,oils, or enzymes maylower efficacy.

• Do not use in themiddle or inner ear.

• Do not use in theeyes.

Warnings:• For external use onlyon wounds.

• Do not use forinfusion or injection.

• Do not ingest.

Storage Conditions:Store at roomtemperature. Do notrefrigerate. Protectfrom freezing.

Preservation and shelf-life: Use prior to expirationdate noted on thepackage label.Although no longersterile once the tubehas been opened,because of

preservative, there is ashelf-life of 8 weeksafter first opening thetube. Close immediatelyafter use and protectthe top of the tubefrom contamination ordirect contact.

Instructions For UseFor general use:Rinsing and cleansingthe wound andsurrounding area isrecommended prior toapplication ofProntosan Wound Gel X.Prontosan WoundIrrigation Solution canbe used for thispurpose. Refer tocleansing solutioninstructions for use.

Apply a generousamount of ProntosanWound Gel X directlyto the wound.

Prontosan Wound Gel Xcan be used to sustainwound moisture for theduration of timebetween dressingchanges perinstitutional protocol.

Directions: UseAseptic Technique. 1. Remove capfrom tube.

2. Invert screw capand press keyedindent on captop onto keyedsealed tube.Ensure cap isfirmly seated.Rotate cap toopen the seal onthe tube.

3. Proceed withuse as requiredin accordancewithinstitutionalprotocol.

4. Replace cap after use inaccordance withinstitutionalprotocol.

Manufactured for:B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA1-800-227-2862