Chloraprep® Swabsticks

Chloraprep® Swabsticks
SPL v5
SPL
SPL Set ID f06e4f9d-6cef-b57a-e053-2a95a90a7337
Route
TOPICAL
Published
Effective Date 2017-09-22
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 2002-10-07

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 or injection. 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)
  • tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
  • 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. Do not blot or wipe away.
  • 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 ºC (59-86 °F)
  • avoid freezing and excessive heat above 40 ºC (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.

Package/label Principal Display Panel

PRINCIPAL DISPLAY PANEL-CARTON

1.75ml

SINGLE SWABSTICK

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

48 applicators

0.06 fl. oz. (1.75 ml) each

NDC 054365-400-07

Cat. No. 2601000

ChloraPrep ® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is non-sterile

Professional Use Only

Store between 15-30 ºC (59-86 ºF)

Avoid freezing and excessive heat

above 40 ºC (104 ºF)


Structured Label Content

Use

for the preparation of the patient's skin prior to surgery or injection. 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)
  • tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
  • 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. Do not blot or wipe away.
  • 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 (Other information)
  • store between 15-30 ºC (59-86 °F)
  • avoid freezing and excessive heat above 40 ºC (104 °F)
Active Ingredients (Active ingredients)

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Inactive Ingredient (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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

PRINCIPAL DISPLAY PANEL-CARTON

1.75ml

SINGLE SWABSTICK

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

48 applicators

0.06 fl. oz. (1.75 ml) each

NDC 054365-400-07

Cat. No. 2601000

ChloraPrep ® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is non-sterile

Professional Use Only

Store between 15-30 ºC (59-86 ºF)

Avoid freezing and excessive heat

above 40 ºC (104 ºF)


Advanced Ingredient Data


Raw Label Data

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