PerioGard Description

PerioGard® (Chlorhexidine Gluconate Oral rinse USP, 0.12%) is an oral rinse containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. PerioGard® product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

PerioGard - Clinical Pharmacology

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use.

Use of chlorhexidine gluconate oral rinse USP, 0.12% in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse USP, 0.12% use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

Indications and Usage for PerioGard

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. PerioGard® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Contraindications

PerioGard® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Warnings

The effect of PerioGard® on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse USP, 0.12% compared with control users. It is not known if chlorhexidine gluconate use results in an increase of subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS.

Precautions

Adverse Reactions/Side Effects

The most common side effects associated with chlorhexidine gluconate oral rinse USP, 0.12% are: (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.

Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse USP, 0.12% are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

Overdosage

Ingestion of 1 or 2 ounces of PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of PerioGard® Oral Rinse is ingested by a small child.

PerioGard Dosage and Administration

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

How is PerioGard supplied

PerioGard® is supplied as a blue liquid in a 16-fluid ounce (473 mL) (NDC 0126-0282-16) amber plastic bottle with child-resistant dosage cap.

Colgate Oral Pharmaceuticals, Inc.,
a subsidiary of Colgate-Palmolive Company
New York, NY 10022 U.S.A.
Questions/Comments: 1-800-962-2345
www.colgateprofessional.com

Revised: December 2019

To open child safety cap, squeeze smooth sides while turning. To close, turn until cap stops.

DIRECTIONS FOR USE: Fill cap to the fill line (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed.

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

INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1.

WHAT TO EXPECT WHEN USING PERIOGARD® (CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%): Your dentist has prescribed PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use PerioGard® regularly, as directed by your dentist, in addition to daily brushing and flossing. Spit out after use; PerioGard® should not be swallowed.

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

PerioGard® may cause some tooth discoloration, or increase 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 or 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. PerioGard® may cause permanent discoloration of some front-tooth fillings.
• To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.
• PerioGard® 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 PerioGard®.
• To avoid taste interference, rinse with PerioGard® after meals. Do not rinse with water or other mouthwashes immediately after rinsing with PerioGard®.

If you have any questions or comments about PerioGard®, contact your dentist, pharmacist or Colgate toll free at: 1-800-962-2345.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Rx Only. Keep out of reach of children.

Colgate Oral Pharmaceuticals, Inc.,
a subsidiary of Colgate-Palmolive Company
New York, NY 10022 U.S.A.
Questions/Comments: 1-800-962-2345
www.colgateprofessional.com

Revised: December 2019

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Colgate®

NDC 0126-0282-16

PerioGard®
(Chlorhexidine Gluconate
Oral Rinse USP, 0.12%)

ALCOHOL FREE

Rx Only

PLACE PHARMACY
LABEL HERE

Dispense in original container
or in amber glass.

KEEP OUT OF REACH OF CHILDREN
For questions or comments contact
your dentist or pharmacist.

16 FL OZ (1 PT) 473 mL