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Prevantics Maxi Swabstick by Professional Disposables International, Inc.

Dosage form: solution
Ingredients: CHLORHEXIDINE GLUCONATE 31.5mg in 1mL, ISOPROPYL ALCOHOL 0.7mL in 1mL
Labeler: Professional Disposables International, Inc.
NDC Code: 10819-4075

S41950- NDC-10819-4075-4

Active ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

Antiseptic

Use

for the preparation of the patient's skin prior to surgery or injection

Warnings
  • For external use only
  • Flammable, keep away from fire or flame
  • Do not use with electrocautery procedures

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.

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 maxi swabstick is approximately: dry site: 7 by 7 inches (18 by 18 cm) or moist site: 3 by 7.5 inches (7.5 by 19 cm)
  • peal apart the pouch to expose the swabstick
  • remove swabstick from package. Do not touch the foam tip.
  • prior to surgery or injection, apply swabstick to the procedure site
  • place one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes for one (1) minute
  • turn the swabstick over (unused side of the foam tip) and repeat the procedure by prepping for one (1) minute
  • allow the prepped area to air dry for one and one half minutes (1.5 minutes)
  • do not blot or wipe dry
  • discard after a single use

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

USP purified water

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.

Package/Label Principal Display Panel

Reorder No. S41950
NDC 10819-4075-4

Prevantics(R) Maxi Swabstick
[Chlorhexidine Gluconate (3.15%)
and Isopropyl Alcohol (70%) Swab]

Patient preoperative skin preparation
Non-sterile solution

  • For external use only
  • Single step, broad spectrum, persistent antiseptic that significantly reduces the number of microorganisms on intact skin
  • Use for the preparation of the patient's skin prior to surgery or injection
  • Helps reduce bacteria that potentially can cause skin infection
  • Latex free
  • For hospital and professional use only

IMPORTANT: See carton for complete Drug Factsand safety information.

Packet Label

Box Label

PREVANTICS MAXI SWABSTICK 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-4075
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE31.5 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:10819-4075-430 POUCH in 1 BOX
15.1 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02152401/15/2013
Labeler - Professional Disposables International, Inc. (800777117)
Establishment
NameAddressID/FEIOperations
Professional Disposables International, Inc.800777117manufacture(10819-4075)

Revised: 10/2017
 
Professional Disposables International, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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