Chlorhexidine

Name: Chlorhexidine

Uses of Chlorhexidine

Chlorhexidine is a prescription medication used to treat gingivitis, redness and swelling of gums, and to control gum bleeding. It is also used to help treat peridontitis, or gum disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Chlorhexidine Brand Names

Chlorhexidine may be found in some form under the following brand names:

  • Avagard

  • Bactoshield

  • Betasept

  • Calgon Vesta

  • CHG Teat Dip

  • ChloraPrep One-Step

  • Chlorostat

  • Chlorostat 4

  • CHX Plus

  • Dairyland Brand Sprayable CHG Teat Dip

  • Denti-Rinse

  • Dyna-Hex

  • E-Z Scrub

  • Excel

  • Foam Safe

  • Hex-O-Prep

  • Hexi-Dip 110

  • Hexidip

  • Hibiclens

  • Hibistat

  • KleerSight

  • Malaseb

  • Milkhouse Brand Sprayable CHG Teat Dip

  • Monarch Protek

  • Paroex

  • Peridex

  • PerioChip

  • Periogard

  • Perisol

  • Prevantics

  • Pro Pet Antiseptic

  • Pro Pet Dental Cleansing Liquid

  • Pro Pet Dental Wipes

  • Septi-Soothe

  • Spectrum-4

  • Super 2X

  • Supreme

  • Tru-Blu C-Hex 110

  • Tru-Blu Chlor Hex-Wash

  • Vet One

  • Vital-Chlor

  • Vital-Ketodine

Chlorhexidine Precautions

Serious side effects have been reported with chlorhexidine including the following:

  • Allergic symptoms. Tell your health care provider right away if you have some or all of the following symptoms of allergic symptoms.
    • skin rash
    • itch
    • generalized swelling
    • breathing difficulties
    • light headedness
    • rapid heart rate
    • upset stomach
    • diarrhea
  • Pain or swelling. Notify your dentist promptly if pain, swelling, or other problems occur. (Some mild to moderate sensitivity is normal during the first week after placement of chip)

Do not use chlorhexidine if you have a known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Proper Use of chlorhexidine

Chlorhexidine oral rinse should be used after you have brushed and flossed your teeth. Rinse the toothpaste completely from your mouth with water before using the oral rinse. Do not eat or drink for several hours after using the oral rinse.

The cap on the original container of chlorhexidine can be used to measure the 15 mL (½ fluid ounce) dose of chlorhexidine. Fill the cap to the ``fill line.'' If you do not receive the dental rinse in its original container, make sure you have a measuring device to measure out the correct dose. Your pharmacist can help you with this.

Swish chlorhexidine around in the mouth for 30 seconds. Then spit out. Use the medicine full strength. Do not mix with water before using. Do not swallow the medicine.

Dosing

The dose of chlorhexidine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of chlorhexidine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral rinse dosage form:
    • For gingivitis:
      • Adults—Use 15 milliliters (mL) as a mouth wash for 30 seconds two times a day.
      • Children up to 18 years of age—Use and dose must be determined by your dentist or medical doctor.

Missed Dose

If you miss a dose of chlorhexidine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Chlorhexidine Description

Chlorhexidine Gluconate Oral Rinse, 0.12% is an oral rinse containing 0.12% Chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di- D- gluconate) in a base containing 11.6% v/v alcohol, FD&C Blue No. 1, glycerin, natural and artificial peppermint flavor, PEG-40 sorbitan diisostearate, saccharin sodium, and purified water. Chlorhexidine Gluconate Oral Rinse, 0.12% is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of Chlorhexidine and gluconic acid. Its chemical structure is:

Contraindications

Chlorhexidine gluconate oral rinse, 0.12% should not be used by persons who are known to be hypersensitive to Chlorhexidine gluconate or other formula ingredients.

Warnings

The effect of Chlorhexidine gluconate oral rinse, 0.12% 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 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).

Chlorhexidine Dosage and Administration

Chlorhexidine gluconate oral rinse, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using Chlorhexidine gluconate oral rinse, 0.12% 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 (marked in cap) of undiluted Chlorhexidine gluconate oral rinse, 0.12%. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Chlorhexidine gluconate oral rinse, 0.12%. Chlorhexidine gluconate oral rinse, 0.12% is not intended for ingestion and should be expectorated after rinsing.

Package/Label Display Panel

NDC 50383-720-16

Chlorhexidine GLUCONATE ORAL RINSE, 0.12%

Measuring cup is shrink wrapped to container for your protection. Remove shrink wrap and dosage cup. Press down while turning counterclockwise to open container. To reseal,turn cap clockwise until tightly locked.

DIRECTIONS FOR USE: Fill measuring cup to the fill line (1/2 ounce). Swish in mouth undiluted for 30 seconds twice daily, after breakfast and before bedtime, expel reminder. Or, use as prescribed.

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

INGREDIENTS: 0.12% Chlorhexidine gluconate in a base containing 11.6% alcohol, FD&C Blue No. 1, glycerin, natural and artificial peppermint flavor, PEG-40 sorbitan diisostearate, saccharin sodium and purified water.

Rx only

PLACE PHARMACY LABEL HERE.

Dispense in original container or in amber glass.

STORE ABOVE FREEZING 0°c (32°F).

Keep out of reach of children.

16 fl oz (473 mL)

Chlorhexidine GLUCONATE 
Chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-720
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
ALCOHOL  
FD&C BLUE NO. 1  
GLYCERIN  
PEG-40 SORBITAN DIISOSTEARATE  
PEPPERMINT  
SACCHARIN SODIUM  
WATER  
Product Characteristics
Color BLUE Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:50383-720-16 473 mL in 1 BOTTLE, PLASTIC
2 NDC:50383-720-17 4 TRAY in 1 CASE
2 10 CUP, UNIT-DOSE in 1 TRAY
2 NDC:50383-720-10 10 mL in 1 CUP, UNIT-DOSE
3 NDC:50383-720-19 10 TRAY in 1 CASE
3 10 CUP, UNIT-DOSE in 1 TRAY
3 NDC:50383-720-10 10 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074356 05/07/1996
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
Name Address ID/FEI Operations
Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-720)
Revised: 08/2017   Hi-Tech Pharmacal Co., Inc.
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