Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-31
- Packager: CareFusion 213, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 22, 2021
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- Active Ingredients
- Allergy alert:
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- 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
Principal Display Panel-Carton
BD ChloraPrep Clear
1 mL Applicators
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v Isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
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)
0.03 fl. oz (1 mL) each
Not made with natural rubber latex
Do not reuse
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
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 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:54365-400-31 60 in 1 CARTON 05/24/2019 1 1 in 1 POUCH 1 1 mL in 1 APPLICATOR; Type 0: Not a Combination 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 - CareFusion 2200, Inc (832696038) Establishment Name Address ID/FEI Business Operations CareFusion 213, LLC 826496312 analysis(54365-400) , label(54365-400) , manufacture(54365-400) , pack(54365-400)