Peridex

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1¹-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse provides antimicrobial activity during oral rinsing. The clinical significance of Peridex 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 Peridex in a six month clinical study did not result in any significant changes in bacteria resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after Peridex 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.

Pharmacokinetic studies with Peridex indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 mcg/g in humans 30 minutes after they ingested a 300mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

Peridex 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. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

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

The effect of Peridex on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Peridex users compared with control users. It is not known if Peridex use results in an increase in 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.

The most common side effects associated with chlorhexidine gluconate oral rinses 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%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Peridex 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 Peridex. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Peridex.

Ingestion of 1 or 2 ounces of Peridex by a small child (~1O kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of Peridex is ingested by a small child or if signs of alcohol intoxication develop.

Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex 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 15ml (marked in cap) of undiluted Peridex. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing.

Peridex is supplied as a blue liquid in 4-ounce (118ml), 1-pint (473ml) and 64-ounce (1893ml) white or amber plastic bottles with child-resistant dispensing closures.

NDC 48878-0620-1

PERIDEX™

(CHLORHEXIDINE GLUCONATE 0.12%)

ORAL RINSE

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.

Rx only

KEEP OUT OF REACH OF CHILDREN

Dispense in bottle as provided or in amber glass

REF 12132

3M ESPE I.D. No.

70-2010-5520-2

PERIDEX16EZCD

1 Pint (473ml)

3M ESPE

INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol,

glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No.1.

To Open: Squeeze smooth areas near bottom of cap and turn. To Close: Turn cap until it locks.

What to expect when using Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse

Your dentist has prescribed Peridex™

(Chlorhexidine Gluconate 0.12%) Oral Rinse to

treat your gingivitis, to help reduce the redness

and swelling of your gums, and also to help you

control any gum bleeding. Use Peridex regularly,

as directed by your dentist, in addition to daily

brushing. Spit out after use, Peridex 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. Peridex should not be used by

persons who have a sensitivity to it or its

components.

Peridex 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. Peridex may cause permanent

discoloration of some front-tooth fillings.

• To minimize discoloration, you should brush and

floss daily, emphasizing areas which begin to

discolor.

• Peridex 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 Peridex.

• To avoid taste interference, rinse with Peridex

after meals. Do not rinse with water or other

mouthwashes immediately after rinsing with

Peridex.

If you have any questions or comments about

Peridex, contact your dentist, pharmacist or 3M

ESPE Dental Products toll free at 1-800-634-2249.

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].

INCIRC™