Prevantics Maxi Swabstick
chlorhexidine gluconate and isopropyl alcohol · Solution · Topical
Active ingredient
Active ingredients Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v
Purpose
Purposes Antiseptic Antiseptic
Uses
Use for the preparation of the patient's skin prior to surgery or injection
Warnings
Warnings For external use only Flammable, k eep away from fire or flame To reduce the risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area 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 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 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
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 under occlusive patch
Ask a doctor before use
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
When using this product
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.
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.
Directions
Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximum treatment area for one swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm). tear open the pouch to expose the swabstick remove swabstick from package. Do not touch the foam tip. prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) halfway in the procedure dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds. moist site: scrub repeatedly for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). do not blot or wipe away discard after a single use
Other information
Other information store between 68-77°F (20-25°C) avoid freezing and excessive heat above 104°F (40°C) for hospital and professional use only
Inactive ingredients
Inactive ingredients USP purified water
Label text from the FDA structured product label by Professional Disposables International, Inc. (revised Jun 30, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Chlorhexidine Gluconate in 1 product
- Isopropyl Alcohol in 1 product
Prevantics Maxi Swabstick NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 10819-4076 | Chlorhexidine Gluconate 31.5 mg/mL; Isopropyl Alcohol .7 mL/mL Solution | Professional Disposables International, Inc. | NDA |
Prevantics Maxi Swabstick recalls
- D-0570-2022 Mar 2, 2022 · Class II · Terminated
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Frequently asked questions
What is Prevantics Maxi Swabstick used for?
Use for the preparation of the patient's skin prior to surgery or injection
Who makes Prevantics Maxi Swabstick?
Prevantics Maxi Swabstick is listed by 1 labeler in the FDA NDC directory, including Professional Disposables International, Inc..
Has Prevantics Maxi Swabstick been recalled?
The FDA enforcement database lists 1 recall for Prevantics Maxi Swabstick, most recently D-0570-2022 (class ii): cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.