Prevantics Maxi Swabstick Solution
FDA Label NDC 10819-4076

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Disposables International, Inc. for the product Prevantics Maxi Swabstick (NDC 10819-4076). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, use, warnings, allergy alert, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

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

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