Drug Detail:Chloraprep one-step (Chlorhexidine topical [ klor-hex-i-deen-top-i-kal ])
Drug Class: Antiseptic and germicides
Indications and Usage for Chloraprep One-Step
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.
- do not use with electrocautery procedures
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurrs, stop use and seek medical help right away.
Do not use
- on patients allergic to chlorhexidine gluconate or any other ingredient in this product
- 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.
Chloraprep One-Step Dosage and Administration
- use with care in premature infants and 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.
Storage and Handling
- store between 15-30 °C (59-86 °F)
- avoid freezing and excessive heat above 40 °C (104 °F)
Package/Label Principal Display Panel
PRINCIPAL DISPLAY PANEL-CARTON
1.5ml
FREPP ®
APPLICATORS
Clear
Do Not Reuse
Not made with natural rubber latex
STERILE EO
20 applicators
0.05 fl. oz. (1.5ml) each
NDC 054365-400-02
Cat. No.260299
ChloraPrep ® One-Step
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Non-sterile Solution
Applicator is sterile if package is intact
Professional Use Only
Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat above 40 °C (104 °F)
CHLORAPREP ONE-STEP
chlorhexidine gluconate and isopropyl alcohol solution |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
Labeler - CareFusion 213 LLC (826496312) |
Registrant - Becton, Dickinson and Company (832696038) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
CareFusion 213 LLC | 826496312 | analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400) , sterilize(54365-400) |