Label: CHLORAPREP SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 54365-401-28, 54365-401-29
- Packager: CareFusion 213 LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 23, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
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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.
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 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.
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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
- one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
- 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): 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.
- Other information
- Inactive ingredient
- Questions?
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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
PRINCIPAL DISPLAY PANEL-CARTON
BD ChloraPrep™ Triple 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
5.25 mL Applicators
NDC 054365-401-29
Ref 930103
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INGREDIENTS AND APPEARANCE
CHLORAPREP SWABSTICK
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-401-28 48 in 1 CARTON 05/13/2024 1 1 in 1 POUCH 1 1.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 2 NDC:54365-401-29 40 in 1 CARTON 05/13/2024 2 3 in 1 POUCH 2 5.25 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021555 05/13/2024 Labeler - CareFusion 213 LLC (826496312) Registrant - Becton, Dickinson and Company (832696038) Establishment Name Address ID/FEI Business Operations CareFusion 213 LLC 826496312 manufacture(54365-401) , analysis(54365-401) , label(54365-401) , pack(54365-401) , sterilize(54365-401)