Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-30
- Packager: CareFusion 213, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
- Warnings
- Allergy alert:
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
• 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 cm2)
• remove applicator from package; do not touch sponge
• hold the applicator 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 of the sponge for approximately 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 approximately 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
- Inactive Ingredient
- Questions?
-
Prinicipal Display Panel-Carton
Principal Display Panel-Carton
BD ChloraPrep FREPP Clear
1.5 mL Applicators
2% w/v chlorhexidine gluconate (CHG)
and 70 % v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Sterile Solution
Applicator is sterile if package is intact
Store between 15-30 oC (59-86 oF)
Avoid freezing and excessive heat above 40 oC (104 oF)
0.05 fl.oz (1.5 mL) each
20 Applicators
Clear
NDC 54365-400-30
REF 930299
Not made with natural rubber latex
Do not reuse
Sterile EO
STERILE SOLUTION
External Use Only
Professional Use Only
CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co. Made in the USA of US and imported parts www.bd.com
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INGREDIENTS AND APPEARANCE
CHLORAPREP ONE-STEP
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400 Route of Administration TOPICAL 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 0.7 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:54365-400-30 20 in 1 CARTON 05/24/2019 1 1 in 1 POUCH 1 1.5 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020832 05/24/2019 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)