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Prevantics Swab 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: 10819-1080

B11400- NDC 10819-1080-2

Active ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Antiseptic

Use

for the preparation of the patient's skin prior to an 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 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.

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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
  • tear open packet and remove swab. Do not unfold swab.
  • prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
  • allow the prepped area to air dry for 30 seconds
  • 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 inlcude:

  • 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. B11400

NDC 10819-1080-2

Prevantics(R) Swab

Chlorhexidine Gluconate (3.15%) and Isopropyl Alcohol (70%) swab

Antiseptic

Non-Sterile Solution

Packagind is sterile when in sterile kits

For external use only

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

Helps reduce bacteria that potentially can case skin infection

For hospital and profesional use only

Latex free

IMPORTANT: See insert for complete Drug Facts and safety information.



Packet label

Insert

PREVANTICS SWAB 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-1080
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:10819-1080-23000 POUCH in 1 CASE
11 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(10819-1080)

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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