Label: PREVANTICS SWAB- chlorhexidine gluconate and isopropyl alcohol solution

  • NDC Code(s): 10819-1080-2
  • Packager: Professional Disposables International, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • 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

    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.

    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

  • Package/Label Principal Display Panel

    Packet label

    label

    Insert insert

  • INGREDIENTS AND APPEARANCE
    PREVANTICS SWAB 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-1080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE31.5 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-1080-23000 in 1 CASE01/15/2013
    11 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02152401/15/2013
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-1080)
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