Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-05
- 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:
- do not use 26-mL applicator for head and neck surgery
- do not use on an area smaller than 8.4 in. × 8.4 in. Use a
smaller applicator instead.
- 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 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
- Do not use 26-ml applicator for head and neck surgery
- remove applicator from package; do not touch sponge
- hold the applicator with the sponge down. Pinch wing
only once to activate the ampules 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
- moist surgical sites (e.g., inguinal fold): use gentle
repeated back-and-forth strokes for 2 minutes
- do not allow solution to pool; tuck prep towels to absorb
solution, and then remove
- 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
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 FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-400-05 1 in 1 POUCH 04/26/2002 1 26 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 04/26/2002 Labeler - CareFusion 213 LLC (826496312) Registrant - CareFusion 2200, Inc (832696038) Establishment Name Address ID/FEI Business Operations CareFusion 213 LLC 826496312 analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)