RxNorm Names
CHLORAPREP ONE-STEP
(chlorhexidine gluconate and isopropyl alcohol)
solution
[CareFusion 213 LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0587e96b-623e-4397-9195-bc5c696df53b| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | New Drug Application |
Use
for the preparation of the patient's skin prior to surgery. Helps to reduce bacterial 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:
- •
- solution contains alcohol and gives off flammable vapors
- •
- avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
- •
- do not use with ignition source (e.g. cautery, laser)
- •
- do not allow solution to pool
- •
- remove all wet materials from prep area
Do not use
- •
- on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
- •
- for lumbar puncture or in contact with the meninges
- •
- 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
- •
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- •
- use in a well ventilated area
- •
- maximal treatment area using three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm2)
- •
- tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
- •
- 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
- •
- moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
- •
- allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
- •
- discard the applicators 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
- •
- store between 15-30 ºC (59-86 °F)
- •
- avoid freezing and excessive heat above 40 ºC (104 °F)
Package/Label Principal Display Panel
NDC 054365-400-08
5.25ml TRIPLE SWABSTICK APPLICATORS
Clear
Single Use
Latex Free
40 packages
0.18 fl. oz. (5.25 ml) each
ChloraPrep®
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
WARNING FLAMMABLE
Keep away from fire or flame.
To reduce risk of fire, PREP CAREFULLY:
- •
- solution contains alcohol and gives off flammable vapors
- •
- avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
- •
- do not use with ignition source (e.g. cautery, laser)
- •
- do not allow solution to pool
- •
- remove wet material from prep area
Store between 15-30 ºC (59-86 ºF)
Avoid freezing and excessive heat above 40 ºC (104 ºF)
| 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) | |
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