Chloraprep One-step Solution
NDC Package 54365-400-07

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.

• use with care in premature infants or infants under 2 months of age.These products may cause irritation or chemical burns.• maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) • remove applicator from package; do not touch sponge• hold the applicator horizontally with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin• completely wet the treatment area with antiseptic• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds. • moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute. • do not blot or wipe away• discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Carefusion 213 Llc

Human Otc Drug

NDA021555

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

10-07-2002

12-31-2026

N

No