CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
CareFusion 213 LLC
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Use
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Warnings
For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:
For external use only. Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:
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- do not use 26-mL applicator for head and neck surgery
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- do not use on an area smaller than 8.4 in. x 8.4 in. Use a small applicator instead.
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- solution contains alcohol and gives off flammable vapors
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- avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
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- 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)
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- do not allow solution to pool
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- remove wet materials from prep area
Do not use
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- on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
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- for lumbar puncture or in contact with the meninges
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- on open skin wounds or as a general skin cleanser
When using this product
keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Directions
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- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
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- use in a well ventilated area
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- maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm2). Do not use 26-ml applicator for area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
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- do not use 26-ml applicator for head and neck surgery
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- remove applicator from package; do not touch sponge
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- hold applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
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- wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
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- completely wet the treatment area with antiseptic
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- dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds
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- moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes.
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- do not allow solution to pool; tuck prep towels to absorb solution, and then remove
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- allow solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
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- 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.
Other information
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- store between 15-30 °C (59-86 °F)
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- avoid freezing and excessive heat above 40 °C (104 °F)
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- the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.
Package/Label Principal Display Panel
Cat. No. 260815
NDC 054365-400-13
Single Use
Applicator is STERILE if package is intact
ChloraPrep® With Tint
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol
Patient Preoperative Skin Preparation
26ml APPLICATOR
Hi-Lite Orange®
WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
CareFusion, Leawood, KS 66211
Made in USA of US and imported parts
| CHLORAPREP ONE-STEP
chlorhexidine gluconate and isopropyl alcohol solution |
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| Labeler - CareFusion 213 LLC (826496312) |
| Registrant - CareFusion 213 LLC (831684456) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| CareFusion 213 LLC | 826496312 | ANALYSIS(54365-400), MANUFACTURE(54365-400), LABEL(54365-400), PACK(54365-400) | |