Label: PERIDEX- chlorhexidine gluconate rinse

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1 1-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 Guconate 0.12%) Oral Rinse provides antimircobial 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.

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 1.0%. 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 (~10 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.

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 healthcare 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].

Revised: October/2015

Made in U.S.A. for:

3M ESPE Dental Products

2510 Conway Avenue

St. Paul, MN 55144-1000 U.S.A.

© 3M 2019

NDC 48878-0620-3

Peridex

(CHLORHEXIDINE GLUCONATE 0.12%)

ORAL RINSE, USP

DIRECTIONS FOR USE: Swish 1 tablespoon (15 ml) 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

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, press down while turning cap. To reseal, turn cap past "clicks" until tightly locked.

4 oz. (118 ml)

REF 12134

PERIDEX04EZCD

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.

70-2010-5520-1

1 Pint (473 ml)

PERIDEX16EZCDA

NDC 48878-0620-2

Peridex

(CHLORHEXIDINE GLUCONATE 0.12%)

ORAL RINSE

DIRECTIONS FOR USE: Remove bottle cap and replace with dispensing pump. Turn pump counterclockwise to release pump spring mechanism and seal. Dispense two complete pumps of the oral rinse, an appropriate deliverable volume of 15 ml, into a suitable patient cup. Swish in mouth undiluted for 30 seconds, then spit out.

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

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.

Rx Only

KEEP OUT OF REACH OF CHILDREN

64 fl oz (1893 ml)

REF 12133

3M ESPE I.D. No.

70-2010-5521-0

3M ESPE

64PERIEZCDLBL