Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-05, 54365-400-13, 54365-400-14
- Packager: CareFusion 213 LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 13, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME
Keep away from fire or flame.
To reduce risk of fire, PREP CAREFULLY:
- do not use 26-ml applicator for head and neck surgery or 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
- Active ingredients
- Purposes
- Use
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Warnings
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. x 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
Allergy alert:
This product may cause a severe allergic
reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help
right away.
Do not use
- on patients allergic to chlorhexidine gluconate or any other ingredient in this product
- for lumbar puncture or in contact with the meningea
- 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.
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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.
- use in a well ventilated area
- maximal treatment area for one applicator is approximately
13.2 in. x 13.2 in. (1126 cm 2). Do not use 26-ml applicator
for area smaller than 8.4 in. x 8.4 in. Use a smaller
applicator instead,
- do not use 26-ml applicator for head and neck surgery
- remove applicator from package; do not touch sponge
- hold 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 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 ingredient
- Questions?
- Package Label: 26mL Applicators Non-Sterile Solution: Clear, Hi-Lite Orange, Scrub Teal
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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:54365-400-14 1 in 1 POUCH 07/14/2000 02/28/2021 1 26 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 2 NDC:54365-400-13 1 in 1 POUCH 08/18/2006 02/28/2021 2 26 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 3 NDC:54365-400-05 1 in 1 POUCH 04/26/2002 02/28/2021 3 26 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 07/14/2000 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)