Label: SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate kit
Contains inactivated NDC Code(s)
NDC Code(s): 53462-003-15, 53462-007-27, 53462-705-23
- Packager: Sage Products LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 29, 2019
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CHLORHEXIDINE GLUCONTATE 0.12% ORAL RINSE
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&C Blue No. 1. Chlorhexidine Gluconate is a near-neutral solution (pH range 5-7). Chlorhexidine Gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:
Chlorhexidine Gluconate Oral Rinse 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 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 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 Chlorhexidine Gluconate Oral Rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released in 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 300 mg 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.
INDICATIONS AND USAGE
Chlorhexidine Gluconate Oral Rinse 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. Chlorhexidine Gluconate Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
The effect of Chlorhexidine Gluconate Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Chlorhexidine Gluconate Oral Rinse users compared with control users. It is not known if Chlorhexidine Gluconate Oral Rinse 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.
- For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Chlorhexidine Gluconate Oral Rinse should not be used as a major indicator of underlying periodontitis.
- Chlorhexidine Gluconate Oral Rinse 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 toothstaining. In clinical testing, 56% of Chlorhexidine Gluconate Oral Rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Chlorhexidine Gluconate Oral Rinse 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 use of Chlorhexidine Gluconate Oral Rinse 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 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.
- Some patients may experience an alteration in taste perception while undergoing treatment with Chlorhexidine Gluconate Oral Rinse. Rare instances of permanent taste alteration following Chlorhexidine Gluconate Oral Rinse use have been reported via post-marketing product surveillance.
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 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.
Ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse 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 Chlorhexidine Gluconate Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.
DOSAGE AND ADMINISTRATION
Chlorhexidine Gluconate Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using Chlorhexidine Gluconate Oral Rinse 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 15 mL of undiluted Chlorhexidine Gluconate Oral Rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Chlorhexidine Gluconate Oral Rinse. Chlorhexidine Gluconate Oral Rinse is not intended for ingestion and should be expectorated after rinsing.
- HOW SUPPLIED
PATIENT PACKAGE INSERT
Rx only. KEEP OUT OF REACH OF CHILDREN.
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.
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. Chlorhexidine Gluconate Oral Rinse should not be used by persons who have a sensitivity to it or its components.
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.
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.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
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].
Sage Products LLC
Cary, IL 60013
Revised: October, 2018
- 2% CHLORHEXIDINE GLUCONATE CLOTH
For external use only
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- facial swelling
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- on patients allergic to chlorhexidine gluconate or any other ingredient in this product
- for lumbar punctures or in contact with the meninges
- on open skin wounds or as a general skin cleanse
When using this product
- keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
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.
- KEEP OUT OF REACH OF CHILDREN
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- do not microwave
- product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.
To open package
- holding top of package in one hand, lift flap on backside of package with other hand
- grasp flap at top and pull down to tear flap away and expose foam
- hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
- using sterile scissors, cut off end seal of package
- transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
- use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.
- dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse.
- moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse.
- discard each cloth after a single use
- after package has been opened discard any unused cloths
- store product flat
- store between 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS
chlorhexidine gluconate kit
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-007 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-007-27 1 in 1 KIT 02/06/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 6 Part 2 1 BOTTLE 4 mL Part 3 1 BOTTLE 15 mL Part 1 of 3 CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate cloth
Product Information Item Code (Source) NDC:53462-705 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 500 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NONOXYNOL-9 (UNII: 48Q180SH9T) POLYSORBATE 20 (UNII: 7T1F30V5YH) DIMETHICONE 350 (UNII: 2Y53S6ATLU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) GLUCONOLACTONE (UNII: WQ29KQ9POT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-705-23 6 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021669 02/01/2006 Part 2 of 3 3M SKIN AND NASAL ANTISEPTIC
Product Information Item Code (Source) NDC:17518-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength LACTIC ACID (UNII: 33X04XA5AT) MALIC ACID (UNII: 817L1N4CKP) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM IODIDE (UNII: F5WR8N145C) STEARETH-100 (UNII: 4OH5W9UM87) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 KIT 1 4 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/01/2009 Part 3 of 3 CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE
chlorhexidine gluconate liquid
Product Information Item Code (Source) NDC:53462-003 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-003-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077789 01/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021669 02/06/2012 Labeler - Sage Products LLC (054326178) Registrant - Sage Products LLC (054326178) Establishment Name Address ID/FEI Business Operations Sage Products LLC 054326178 manufacture(53462-007, 53462-705)