ChloraPrep Swabstick CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL CAREFUSION 213 LLC FDA Approved Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection. Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
FunFoxMeds box
Route
TOPICAL
Applications
NDA021555

Drug Facts

Composition & Profile

Active Ingredients
BD ChloraPrep™ Single Swabstick 1.75 mL Applicators Active ingredients Chlorhexidine gluconate (CHG) 2% w/v and Isopropyl alcohol (IPA) 70% v/v BD ChloraPrep™ Triple Swabstick 5.25 mL Applicators Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v
Inactive Ingredients
Inactive ingredient USP purified water Inactive ingredient USP purified water
Strengths
1.75 ml 2 % 70 % 5.25 ml
Quantities
75 ml 25 ml
Treats Conditions
Use For The Preparation Of The Patient S Skin Prior To Surgery Helps To Reduce Bacteria That Potentially Can Cause Skin Infection

Identifiers & Packaging

Container Type BOX
UNII
MOR84MUD8E ND2M416302
Packaging

BD ChloraPrep™ Single Swabstick Package/Label Principal Display Panel PRINCIPAL DISPLAY PANEL-CARTON BD ChloraPrep™ Single Swabstick Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 1.75 mL Applicators NDC 054365-401-28 Ref 930100 Foil Pouch Front-Single Swabstick Foil Pouch Back-Single Swabstick Carton - Single Swabstick; BD ChloraPrep™ Triple Swabsticks Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 5.25 mL Applicators NDC 54365-401-29 REF 930103 Foil Pouch front-Triple Swabsticks Foil Pouch Back-Triple Swabsticks Carton-Triple Swabsticks

Package Descriptions
  • BD ChloraPrep™ Single Swabstick Package/Label Principal Display Panel PRINCIPAL DISPLAY PANEL-CARTON BD ChloraPrep™ Single Swabstick Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 1.75 mL Applicators NDC 054365-401-28 Ref 930100 Foil Pouch Front-Single Swabstick Foil Pouch Back-Single Swabstick Carton - Single Swabstick
  • BD ChloraPrep™ Triple Swabsticks Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 5.25 mL Applicators NDC 54365-401-29 REF 930103 Foil Pouch front-Triple Swabsticks Foil Pouch Back-Triple Swabsticks Carton-Triple Swabsticks

Overview

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

Indications & Usage

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

Dosage & Administration

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 one single swabstick 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 repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 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 repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 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. 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 using three swabsticks sequentially is approximately 5 in. x 5 in. (160 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): using each swabstick sequentially, use repeated back-and-forth strokes for a total of 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): using each swabstick sequentially, use repeated back-and-forth strokes for a total of 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.

Warnings & Precautions
Warnings For external use only. Flammable, keep away from fire or flame. do not use with electrocautery procedures 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. Warnings For external use only. Flammable, keep away from fire or flame. do not use with electrocautery procedures 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.
Purpose

Purpose Antiseptic Purposes Antiseptic Antiseptic

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 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

When Using

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. When using this product keep out of eyes, ears, and mouth. May cause serious or permanent inury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop Use & Ask a Doctor

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information store between 15-30 ºC (59-86 °F) avoid freezing and excessive heat above 40 ºC (104 °F) Other information store between 15-30 ºC (59-86 °F) avoid freezing and excessive heat above 40 ºC (104 °F)

Questions

Questions? www.chloraprep.com call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) Questions? www.chloraprep.com call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)


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