Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 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. 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]. Rx only Keep out of reach of children Revised: July 2022 Made in U.S.A. for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA ©3M 2022; Principal Display Panel - Peridex Bottle Label 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™ Principal Display Panel - Peridex Bottle Label
- HOW SUPPLIED: 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. 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]. Rx only Keep out of reach of children Revised: July 2022 Made in U.S.A. for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA ©3M 2022
- Principal Display Panel - Peridex Bottle Label 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™ Principal Display Panel - Peridex Bottle Label
Overview
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: Chemical Structure
Indications & Usage
INDICATION: 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 .
Dosage & Administration
: 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.
Warnings & Precautions
WARNINGS: 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 .
Contraindications
: Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Adverse Reactions
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.
Storage & Handling
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]. Rx only Keep out of reach of children Revised: July 2022 Made in U.S.A. for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA ©3M 2022
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