Label: PREVANTICS MAXI SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution
- NDC Code(s): 10819-4076-3, 10819-4076-4
- Packager: Professional Disposables International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 30, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
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Warnings
For external use only
Flammable, keep 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.
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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.
- 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
- Inactive ingredients
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Package/Label Principal Display Panel
Prevantics(R) Maxi Swabstick
[Chlorhexidine Gluconate (3.15%)* and Isopropyl Alcohol (70%) Swab]
Patient preoperative skin preparation
Non-sterile solutionPackaging is sterile when in sterile kit
*equivalent to 161 mg of Chlorhexidine Gluconate per pouch
- For External Use Only
- Use for the preparation of the patient's skin prior to surgery or injection
- Helps reduce bacteria that potentially can cause skin infection
- For hospital and professional use only
- Latex free
IMPORTANT: See carton for complete Drug Factsand safety information.
Packet Label
Box Label
Packet (bulk):
Insert:
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INGREDIENTS AND APPEARANCE
PREVANTICS MAXI SWABSTICK
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-4076 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 31.5 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:10819-4076-4 30 in 1 BOX 12/01/2023 1 5.1 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:10819-4076-3 300 in 1 CASE 09/01/2023 2 5.1 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021524 01/01/2020 Labeler - Professional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Professional Disposables International, Inc. 800777117 manufacture(10819-4076)