Chlorhexidine Gluconate (Page 2 of 2)

OVERDOSAGE

Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (~10kg 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 rinsing for 30 seconds, morning and evening after tooth brushing. 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

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 mL) white plastic unit dose cups (NDC 60687-616-44) in 40 count (NDC 60687-616-64) and 100 count (NDC 60687-616-16) packages.

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].

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 Xttrium Laboratories at 1-800-587-3721 or to FDA at 1-800-FDA-1088.

STORE at 20°C to 25°C (68°F to 77°F), 30°C (59°F to 86°F) [See USP controlled Room Temperature].

Rx Only.

KEEP OUT OF REACH OF CHILDREN

DO NOT USE IF SEAL IS BROKEN

Revised: July 2021

Distributed by:
American Health Packaging
Columbus, OH 43217

1999AHPUDINST

Package/Label Display Panel

Chlorhexidine Gluconate Label
(click image for full-size original)

15-mL UNIT DOSE

Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Rx Only

FOR INSTITUTIONAL USE ONLY

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].

Package/Label Display Panel – Cup — 0.12% per 15mL

0.12%/15mL Chlorhexidine Gluconate Oral Rinse Cup
(click image for full-size original)

Rx Only

NDC 60687-616-44

Chlorhexidine Gluconate
Oral Rinse, USP

0.12%

Delivers 15 mL

See package insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging Columbus, OH 43217

1999AHPLIDLBL

CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
GLYCERIN
PEG-40 SORBITAN DIISOSTEARATE
SACCHARIN SODIUM
FD&C BLUE NO. 1
Product Characteristics
Color blue Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-616-64 4 TRAY in 1 CASE contains a TRAY (60687-616-50)
1 NDC:60687-616-50 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (60687-616-64) and contains a CUP, UNIT-DOSE (60687-616-44)
1 NDC:60687-616-44 15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY (60687-616-50) and a CASE (60687-616-64)
2 NDC:60687-616-16 10 TRAY in 1 CASE contains a TRAY (60687-616-50)
2 NDC:60687-616-50 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (60687-616-16) and contains a CUP, UNIT-DOSE (60687-616-44)
2 NDC:60687-616-44 15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY (60687-616-50) and a CASE (60687-616-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077789 08/15/2021
Labeler — American Health Packaging (929561009)

Revised: 08/2021 American Health Packaging

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