FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
3m Duraprep Surgical Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
For external use only. Flammable, keep away from fire or flame.
To reduce the risk of fire, PREP CAREFULLY:
- do not use 26-mL applicator for head and neck surgery
- do not use on an area smaller than 8 in. x 10 in. Use a small applicator instead.
- solution contains alcohol and gives off flammable vapors
- do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- do not allow solution to pool
- remove solution-stained material from prep area
- on patients with known allergies to iodine or any other ingredients in this product
- on open wounds, on mucous membranes, or as a general skin cleanser
- in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism
- keep out of eyes, ears, and mouth. May cause serious injury if permitted to enter and remain. If contact occurs, flush with cold water right away and contact a doctor.
- to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film
- use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- on patients with known allergies to iodine or any other ingredients in this product
- on open wounds, on mucous membranes, or as a general skin cleanser
- in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
patient preoperative skin preparation:
- for preparation of the skin prior to surgery
- helps reduce bacteria that potentially can cause skin infection
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
3m Duraprep Surgical Manufacturers
-
3m Health Care
3m Duraprep Surgical | 3m Health Care
Directions (follow all directions for use)
at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into the sponge. wait for fluid level to reach indicator line of applicator barrel When Applying Solution: DO NOT SCRUB. Paint a single, uniform application and do not reprep area. do not allow solution to pool. Use sponge applicator to absorb excess solution and continue to apply a uniform coating. If solution accidentally gets outside of prep area, remove excess with gauze. clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping. avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Solution will turn from a shiny to a dull appearance on skin alerting the user that the solution is completely dry and no longer flammable. While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution.Do not blot because it may remove solution from skin.
remove solution-stained materials. Replace if necessary. After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all solution-stained materials are removed if incise drapes are used, apply directly to dry prep. On completion of surgical procedure, removal of incise drape will remove film. apply dressing following standard practices -
3m Health Care
3m Duraprep Surgical | 3m Health Care
at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever. with sponge face parallel to the floor, snap lever. Allow all fluid to flow into sponge. When Applying Solution: DO NOT SCRUB. Paint a single, uniform application and do not reprep area. do not allow solution to pool. Use sponge applicator to absorb excess solution and continue to apply a uniform coating. If solution accidentally gets outside of prep area, remove excess with gauze. tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping. avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.
Login To Your Free Account