chlorhexidine gluconate and isopropyl alcohol

FDA Drug Profile — ChloraPrep One-Step, Prevantics Maxi Swabstick, Prevantics Swabstick

Drug Details

Generic Name
chlorhexidine gluconate and isopropyl alcohol
Brand Names
ChloraPrep One-Step, Prevantics Maxi Swabstick, Prevantics Swabstick
Application Number
NDA020832
Sponsor
CareFusion 213, LLC
NDC Codes
12
Dosage Forms
SOLUTION
Routes
TOPICAL
Active Ingredients
CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL

Indications and Usage

Use for the preparation of the patient's skin prior to an injection

Warnings

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 inlcude: 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 ingredients in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch When using this product keep out of eyes, ears, mouth and mucous membranes. 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. Allergy Alert This product may cause a severe allergic reaction. Symptoms may inlcude: wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away.