CHLORHEXIDINE: 8,948 Adverse Event Reports & Safety Profile

DENTI-CARE MEDICOM DENTI-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE MINT Item 10025-H Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1.

Rx

Only KEEP OUT OF REACH OF CHILDREN 1 Pint (473 ml) NDC 64778-0244-1 M0701707V.2 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. To open: Squeeze smooth areas near bottom of cap and turn. To close: Turn Cap until it locks.

What To Expect When Using Chlorhexidine Gluconate Oral Rinse

Your dentist has prescribed chlorhexidine gluconate 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 chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use; Chlorhexidine gluconate oral rinse should not be swallowed. Chlorhexidine gluconate oral rinse 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. 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.
• Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components.
• Chlorhexidine gluconate oral rinse 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 chlorhexidine gluconate oral rinse.
• To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)). Manufactured for and distributed by: AMD Medicom Inc. 2555 Chemin de l'Aviation Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2 DESCRIPTION: Chlorhexidine gluconate 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 and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.

Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available.

Getting Patient

Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into sponge.

When Applying

Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 13.2 in. x 21.6 in. (285.2 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry.

After Applying

Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)

While

Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary.

After

Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available.

Getting Patient

Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge grasp products by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever with sponge face parallel to the floor, snap lever to allow fluid to flow into sponge.

When Applying

Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry.

After Applying

Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)

While

Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary.

After

Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped area. It is not necessary to use the entire amount available.

Getting Patient

Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: remove applicator from package; do not touch sponge grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever with sponge face parallel to the floor, snap lever to allow fluid to flow into sponge.

When Applying

Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 8.4 in. x 15.6 in. (131.4 in 2 ) do not allow solution to pool ; tuck prep towels to absorb solution, and then remove avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry.

After Applying

Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)

While

Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove wet materials from prep area. Replace if necessary.

After

Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Contrainidcations CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse 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 the use of chlorhexidine gluconate oral 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 postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse 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. To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery do not use on an area smaller than 8.4 in. x 15.6 in. Use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PRECAUTIONS: General: 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse USP, 0.12% should not be used as a major indicator of underlying periodontitis. 2. Chlorhexidine gluconate oral rinse USP, 0.12% can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of the chlorhexidine gluconate oral rinse USP, 0.12% users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate oral rinse USP, 0.12% users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from the use of chlorhexidine gluconate oral rinse USP, 0.12% does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse USP, 0.12% treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations. 3. Some patients may experience an alteration in taste perception while undergoing treatment with a chlorhexidine gluconate oral rinse USP, 0.12%. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse USP, 0.12% use have been reported via postmarketing product surveillance. Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing

Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate oral rinse USP, 0.12% is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person’s ingesting 30 mL (2 doses) of chlorhexidine gluconate oral rinse USP, 0.12% per day.

Pediatric

Use: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse USP, 0.12% have not been established in children under the age of 18. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

BD ChloraPrep™ Single Swabstick 1.75 mL Applicators Active ingredients Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v

BD ChloraPrep™ Triple Swabstick 5.25 mL Applicators Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol Questions or comments? call 1-888-827-0624 (8am-5pm, EST, Mon-Fri.) WARNING: This product can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov Dist. by: Avrio Health L.P. Stamford, CT 06901-3431 304978-0A