Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-11
- Packager: CareFusion 213 LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 12, 2019
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- WARNING, FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME
- Active ingredients
For external use only. Flammable, keep away from fire or flame. To reduce the 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 drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
- do not allow solution to pool
- remove wet materials from prep area
Do not use
- 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.
- 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 for one applicator is approximately 4 in. x 5 in. (130 cm 2)
- 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
- moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away.
- If using an ignition source, 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 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 ingredients
Package/Label Principal Display Panel
PRINCIPAL DISPLAY PANEL-CARTON
Do Not Reuse
Not made with natural rubber latex
Professional Use Only
Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat
above 40 °C (104 °F)
0.10 fl. oz. (3 ml) each
Cat. No. 260415
ChloraPrep® With Tint
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Applicator is sterile if package is intact
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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-400-11 25 in 1 CARTON 08/18/2006 1 1 in 1 POUCH 1 3 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 08/18/2006 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)