Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-400-38
- Packager: CareFusion 213, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 22, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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WARNING
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 or 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
- Active ingredients
- Purposes
- Use
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Warnings
For external use only. Flammable, keep away from fire or flame.
To reduce 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:
- 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 • 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 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
- Questions?
- BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Package Label
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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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-400-38 1 in 1 POUCH 05/24/2019 1 26 mL in 1 APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 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) , label(54365-400) , manufacture(54365-400) , pack(54365-400) , sterilize(54365-400)