Paroex
FDA Label NDC 17856-0210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Paroex (NDC 17856-0210). 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 to open, press down while turning the cap. to seal, turn until cap clicks and is tight., what to expect when using paroex® (chlorhexidine gluconate oral rinse usp, 0.12%):, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

To Open, Press Down While Turning The Cap. To Seal, Turn Until Cap Clicks And Is Tight.

Directions for Use: Fill dosage cup to the fill line (15 mL). Swish in your mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.

Note: To minimize medicinal taste, do not rinse with water immediately after use.

Rx Only.

Keep Out Of Reach Of Children.

What To Expect When Using Paroex® (Chlorhexidine Gluconate Oral Rinse Usp, 0.12%):

Your dentist has prescribed Paroex® to treat your gingivitis - to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding.

Use Paroex® regularly, as directed by your dentist, in addition to daily brushing and flossing. Spit out after use. Paroex® should not be swallowed.

If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Paroex® should not be used by persons who have a sensitivity to it or its components.

Paroex® may cause some tooth discoloration, or increases in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain and tartar at least every six months, or more frequently if your dentist advises.

  • Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.
  • To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.
  • Paroex® may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of Paroex®.
  • To avoid taste interference, rinse with Paroex® after meals. Do not rinse with water or other mouthwashes immediately after rinsing with Paroex®.

    • If you have any questions or comments about Paroex®, contact your dentist, pharmacist or Sunstar Americas, Inc. at 1-800-528-8537. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

    Manufactured for: Sunstar Americas, Inc., Chicago, IL 60630

Principal Display Panel

NDC 17856-0210-1

5ml Unit Dose Cup

72 units in a Box

Distributed by:

Atlantic Biologicals Corp

Miami Fl 33179

NDC 17856-0210-2

10 ml Unit Dose Cup

72 units in a Box

Distributed by:

Atlantic Biologicals Corp

Miami Fl 33179

NDC 17856-0210-3

10 ml Unit Dose Cup

72 units in a Box

Distributed by:

Atlantic Biologicals Corp

Miami Fl 33179

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