Chlorhexidine Gluconate (Page 2 of 2)

OVERDOSAGE

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 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 ½ fl. oz. (marked in cup) 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 0. 12% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in original container or in amber glass bottles.

Manufactured by:
Actavis MidAtlantic LLC
7205 Windsor Blvd.
Baltimore, MD 21244 USA

FORM NO. 0036
Rev. 10/06
VC2912

CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0036
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine 0.12 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin
PEG-40 sorbitan diisostearate
peppermint oil
saccharin sodium
FD&C Blue #1
hydrochloric acid
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-0036-16 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
1 473 mL (473 MILLILITER) in 1 BOTTLE This package is contained within the CARTON (0472-0036-16)
Labeler — Actavis Mid Atlantic LLC

Revised: 02/2009 Actavis Mid Atlantic LLC

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