Bd Chloraprep™ Frepp™ Clear 1.5ml Applicators

Bd Chloraprep™ Frepp™ Clear 1.5ml Applicators
SPL v10
SPL
SPL Set ID 8528a4f5-5ff4-45f3-e053-2991aa0a804c
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

Identifiers & Packaging

Marketing Status
NDA Active Since 2019-05-24

Description

Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Purpose

Antiseptic Antiseptic


Medication Information

Purpose

Antiseptic Antiseptic

Description

Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Use

for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Purposes

Antiseptic

Antiseptic

Warnings

For external use only.

Flammable, keep away from fire or flame.

• do not use with electrocautery procedures

Directions

• use with care in premature infants or infants under 2 months of age.

These products may cause irritation or chemical burns.

• maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)

• remove applicator from package; do not touch sponge

• hold the applicator horizontally 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 for 30 seconds. Allow the area to air dry for approximately 30 seconds.

moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute.

• 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)

Active Ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Inactive Ingredient

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™ Frepp™ Clear 1.5 Ml Applicator

Principal Display Panel-Package Label

BD ChloraPrep™ FREPP™ Clear

1.5 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 54365-400-30

REF 930299

Bd Chloraprep™ Frepp™ Clear 1.5 Ml Applicators

Principal Display Panel-Carton

BD ChloraPrep™ FREPP™ Clear

1.5 mL Applicators

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

20 Applicators

NDC 54365-400-30

REF 930299


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.

Purposes

Antiseptic

Antiseptic

Warnings

For external use only.

Flammable, keep away from fire or flame.

• do not use with electrocautery procedures

Directions

• use with care in premature infants or infants under 2 months of age.

These products may cause irritation or chemical burns.

• maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)

• remove applicator from package; do not touch sponge

• hold the applicator horizontally 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 for 30 seconds. Allow the area to air dry for approximately 30 seconds.

moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute.

• 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)

Active Ingredients (Active ingredients)

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Inactive Ingredient

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™ Frepp™ Clear 1.5 Ml Applicator (BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicator)

Principal Display Panel-Package Label

BD ChloraPrep™ FREPP™ Clear

1.5 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 54365-400-30

REF 930299

Bd Chloraprep™ Frepp™ Clear 1.5 Ml Applicators (BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators)

Principal Display Panel-Carton

BD ChloraPrep™ FREPP™ Clear

1.5 mL Applicators

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

20 Applicators

NDC 54365-400-30

REF 930299


Advanced Ingredient Data


Raw Label Data

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