PAROEX (Page 2 of 2)

Dosage and Administration:

Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis. Patients using Paroex® should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily, oral rinsing 30 seconds, morning and evening after toothbrushing. Usual dosage is 15 mL (1/2 FL OZ marked in cup) of undiluted Paroex®. Patients should be instructed not to rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Paroex®. Paroex® is not intended for ingestion and should be expectorated after rinsing.

How Supplied:

Paroex® is supplied as a pink liquid in the following sizes:

4 fl oz (118 ml) (NDC 52376-021-04) amber plastic bottles with child-resistant cap.

16 fl oz (473 mL) (NDC 52376-021-02) amber plastic bottles with child-resistant cap, individually shirnk wrapped with a dosage cup.

STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)

[See USP controlled room temperature].

Rx Only Keep Out Of Reach Of Children

Manufactured for: Sunstar Americas, Inc., 301 E. Central Rd. Schaumburg, IL 60195

Revised: September 2017

Directions for Use:

To open, press down while turning the cap. To seal, turn until cap clicks and is tight.

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

Ingredients:

0.12% chlorhexidine gluconate in a base containing deionized water, propylene glycol, glycerin, polyoxyl 40 hydrogenated castor oil, mint flavor, potassium acesulfame, FD&C Red #40 and D&C Red #33.

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 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 reprot side effects to FDA at 1-800-FDA-1088.

STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)

[See USP controlled room temperature].

Manufactured for: Sunstar Americas, Inc., 301 E. Central Rd. Schaumburg, IL 60195

Principal Display Panel

NDC 052376-021-02 1789P

SUNSTAR

GUM®

Paroex®

CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%

Alcohol Free

Rx Only

KEEP OUT OF REACH OF CHILDREN

PLACE PHARMACY LABEL HERE

Dispense in bottle as provided or amber glass

1 Pint (473 mL)

© Sunstar Americas, Inc. D0C04649 P17265

Chlorhexidine_16_image
(click image for full-size original)
NDC 52376-021-04

1788P

SUNSTAR

GUM®

PAROEX®

Chlorhexidine Gluconate

Oral Rinse USP, 0.12%

ALCOHOL FREE

Rx Only

KEEP OUT OF REACH OF CHILDREN

4 fl oz (118mL)

©Sunstar Americas, Inc.

LBL02303 R04 P17266

Chlohexidine_4_image
(click image for full-size original)
PAROEX
chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52376-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor MINT (Mint Flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52376-021-02 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:52376-021-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076434 04/15/2006
Labeler — Sunstar Americas, Inc. (025066358)

Revised: 05/2018 Sunstar Americas, Inc.

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