3m Soluprep S Solution
NDC Package 17518-082-01

Chlorhexidine Gluconate And Isopropyl Alcohol

Chlorhexidine Gluconate; Isopropyl Alcohol

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped 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:remove applicator from package; do not touch sponge with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into sponge. When Applying Solution:completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 13.2 in. x 21.6 in. (285.2 in2). do not allow solution to pool; tuck prep towels to absorb solution, and then remove clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) 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. 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) 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 wet materials from prep area. 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 wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped 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:remove applicator from package; do not touch sponge grasp products 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 to allow fluid to flow into sponge. When Applying Solution:completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in2). do not allow solution to pool; tuck prep towels to absorb solution, and then remove 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. 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) 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 wet materials from prep area. 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 wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped 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:remove applicator from package; do not touch sponge 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 to allow fluid to flow into sponge. When Applying Solution:completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in2) do not allow solution to pool; tuck prep towels to absorb solution, and then remove 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. 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) 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 wet materials from prep area. 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 wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Solventum Us Llc

Human Otc Drug

NDA208288

NDA - A product marketed under an approved New Drug Application.

01-23-2023

12-31-2027

N

No