Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-07
- Packager: CareFusion 213 LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/vClose
for the preparation of the patient's skin prior to surgery or injection. Helps to reduce bacteria that potentially can cause skin infection.Close
For external use only. Flammable, keep away from fire or flame.
- do not use with electrocautery procedures
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.
Stop use and ask a doctor if
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- maximal treatment area using one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
- 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. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
- 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.
- Other information
- store between 15-30 ºC (59-86 °F)
- avoid freezing and excessive heat above 40 ºC (104 °F)
- Inactive ingredients
- USP purified water
- call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
- Package/Label Principal Display Panel
1.75ml SINGLE SWABSTICK APPLICATORS
Do Not Reuse
Not made with natural rubber latex
0.06 fl. oz. (1.75 ml) each
ChloraPrep ® One-Step
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Applicator is non-sterile
Professional Use Only
Store between 15-30 ºC (59-86 ºF)
Avoid freezing and excessive heat above 40 ºC (104 ºF)Close
- INGREDIENTS AND APPEARANCE
chlorhexidine gluconate and isopropyl alcohol solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL .7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-400-07 48 in 1 CARTON 1 1 in 1 POUCH 1 1.75 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021555 05/10/2005 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)