Bd Chloraprep™ Hi-lite Orange™ 3 Ml Applicator With Sterile Solution
85416361-90b5-3efa-e053-2a91aa0af431
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Keep away from fire or flame. To reduce 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
Purpose
Antiseptic Antiseptic
Medication Information
Purpose
Antiseptic Antiseptic
Description
Keep away from fire or flame. To reduce 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
Use
for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria
that potentially can cause skin infection.
Section 50566-9
irritation, sensitization, or allergic reaction occurs.These may be signs of a serious condition.
Purposes
Antiseptic
Antiseptic
Warnings
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
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 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
• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away.
• 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.
Do Not Use
• on patients allergic to chlorhexidine gluconate or any other ingredient in this product
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser
Questions?
www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
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.
Other Information
• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)
Warning Flammable
Keep away from fire or flame.
To reduce 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
Active Ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Inactive Ingredients
FD&C yellow #6 dye, USP purified water
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.
Keep Out of Reach of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Bd Chloraprep™ Hi Lite Orange™ 3 Ml Applicator With Sterile Solution
Principal Display Panel-Package Label
BD ChloraPrep™ Hi-Lite Orange™
3 mL Applicator
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v Isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Sterile Solution
Applicator is sterile if package is intact
NDC 54365-400-33
REF 930415
Structured Label Content
Use
for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria
that potentially can cause skin infection.
Section 50566-9 (50566-9)
irritation, sensitization, or allergic reaction occurs.These may be signs of a serious condition.
Purposes
Antiseptic
Antiseptic
Warnings
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
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 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
• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away.
• 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.
Do Not Use (Do not use)
• on patients allergic to chlorhexidine gluconate or any other ingredient in this product
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser
Questions?
www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
Allergy Alert: (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.
Other Information
• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)
Warning Flammable (WARNING FLAMMABLE)
Keep away from fire or flame.
To reduce 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
Active Ingredients (Active ingredients)
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Inactive Ingredients
FD&C yellow #6 dye, USP purified water
When Using This Product (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.
Keep Out of Reach of Children. (Keep out of reach of children.)
If swallowed, get medical help or contact a Poison Control Center right away.
Bd Chloraprep™ Hi Lite Orange™ 3 Ml Applicator With Sterile Solution (BD ChloraPrep™ Hi-Lite Orange™ 3 mL Applicator with Sterile Solution)
Principal Display Panel-Package Label
BD ChloraPrep™ Hi-Lite Orange™
3 mL Applicator
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v Isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Sterile Solution
Applicator is sterile if package is intact
NDC 54365-400-33
REF 930415
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:26.951206 · Updated: 2026-03-14T23:13:27.116919