Bd Chloraprep™ Hi-lite Orange™ 26 Ml Applicator With Sterile Solution

Bd Chloraprep™ Hi-lite Orange™ 26 Ml Applicator With Sterile Solution
SPL v8
SPL
SPL Set ID 85791e13-4103-19fe-e053-2991aa0a647f
Route
TOPICAL
Published
Effective Date 2019-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (20 mg) Isopropyl Alcohol (0.7 mL)
Inactive Ingredients
Water Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
NDA Active Since 2019-05-24

Description

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

Purpose

Antiseptic Antiseptic


Medication Information

Purpose

Antiseptic Antiseptic

Description

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

Use

for the preparation of the patient’s skin prior to surgery. Helps to reduce

bacteria that potentially can cause skin infection.

Warning

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
Purposes

Antiseptic

Antiseptic

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
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.

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 oC (59-86 oF)

• avoid freezing and excessive heat above 40 oC (104 oF) • the tint will slowly fade

from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

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.

Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Bd Chloraprep™ Hi Lite Orange™ 26 Ml Applicator Package Label

Package Label

BD ChloraPrep™ Hi-Lite Orange™

26 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

REF 930815

NDC 54365-400-38


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.

Warning (WARNING)

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
Purposes

Antiseptic

Antiseptic

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
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.

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 oC (59-86 oF)

• avoid freezing and excessive heat above 40 oC (104 oF) • the tint will slowly fade

from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition.

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™ 26 Ml Applicator Package Label (BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Package Label)

Package Label

BD ChloraPrep™ Hi-Lite Orange™

26 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

REF 930815

NDC 54365-400-38


Advanced Ingredient Data


Raw Label Data

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