OTC Medication Information: Prevantics Maxi Swabstick

PREVANTICS MAXI SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution
Professional Disposables International, Inc.

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

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.

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)
  • 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) hlf way 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 back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 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

Package/Label Principal Display Panel

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 Facts and safety information.

Packet Label

packet
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Box Label

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Packet (bulk):

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Insert:

insert
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PREVANTICS MAXI SWABSTICK
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-4076
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 31.5 mg in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10819-4076-4 30 POUCH in 1 BOX contains a POUCH
1 5.1 mL in 1 POUCH This package is contained within the BOX (10819-4076-4)
2 NDC:10819-4076-3 300 POUCH in 1 CASE contains a POUCH
2 5.1 mL in 1 POUCH This package is contained within the CASE (10819-4076-3)
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 Operations
Professional Disposables International, Inc. 800777117 manufacture (10819-4076)

Revised: 10/2019 Professional Disposables International, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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