Q2 Oral Care Kit with CHG (Page 2 of 2)

Pediatric Use

Clinical effectiveness and safety of Chlorhexidine Gluconate Oral Rinse, 0.12% have not been established in children under the age of 18

Carcinogenesis, Mutagenesis, and 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.

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 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 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse, 0.12% 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, 0.12%.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentis) reported in patients using chlorhexidine gluconate oral rinse.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse, 0.12% 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, 0.12% is ingested by a small child or if signs of alcohol intoxication develop.

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 1/2 fl oz (marked in cup) 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.

HOW SUPPLIED

Chlorhexidine Gluconate Oral Rinse, 0.12% is a blue, peppermint flavored liquid in:

A 16 fl oz (473 mL) amber plastic bottle with a child-resistant closure and dosage cup for consumer use, and in 15 mL unit dose cups.

It should be dispensed in original container or in amber glass.

Store above freezing 0°C (32°F).

Rx only

Manufactured by:
Hi-Tech
Pharmacal Co., Inc.
Amityville, NY 11701

Rev. 720:00 7/10
MG# 11387

PRINCIPAL DISPLAY PANEL — Kit Carton

HALYARD*

24-HOUR
ORAL CARE KIT
with BALLARD* Technology

Use
with
CHG

CHG

with
H2 O2

q2

1
HALYARD*
Prep
Pack

2
HALYARD*
Toothbrush
Packs

4
HALYARD*
Suction Swab
Packs with H2 O2

6
HALYARD*
Suction Swab Packs
with Alcohol-Free Mouthwash

2
HALYARD*
Suction CatheterPacks

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Alcohol free mouthwash Mouthwashes and Breath Fresheners (liquids and sprays)
Mouth Moisturizer other oral hygiene products
Q2 ORAL CARE KIT WITH CHG hydrogen peroxide and chlorhexidine gluconate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69697-982
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69697-982-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4 CUP, UNIT-DOSE 56 mL
Part 2 6 CUP, UNIT-DOSE 84 mL
Part 3 10 TUBE 100 g
Part 4 10 CUP, UNIT-DOSE 150 mL
Part 1 of 4
HYDROGEN PEROXIDE hydrogen peroxide mouthwash
Product Information
Item Code (Source) NDC:69697-991
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrogen peroxide (Hydrogen peroxide) Hydrogen peroxide 0.015 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Mint
Saccharin Sodium Dihydrate
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69697-991-01 14 mL in 1 CUP, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 08/26/2008
Part 2 of 4
ALCOHOL FREE MOUTHWASH inert mouthwash
Product Information
Route of Administration ORAL DEA Schedule
Ingredients
Ingredient Name Quantity
water
Benzoic Acid
Saccharin Sodium Dihydrate
Sodium Benzoate
Glycerin
Cetylpyridinium Chloride
D&C Green no. 5
Sorbitol
Mint
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 14 mL in 1 CUP, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/13/2008
Part 3 of 4
MOUTH MOISTURIZER inert unassigned
Product Information
Route of Administration ORAL DEA Schedule
Ingredients
Ingredient Name Quantity
water
Xylitol
Sodium Benzoate
Aloe Vera Leaf
Propylene Glycol
Potassium Sorbate
Sorbitol
Hydroxypropyl Cellulose (Type H)
Dimethicone
Potassium Chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 10 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 06/25/2008
Part 4 of 4
CHLORHEXIDINE GLUCONATE chlorhexidine gluconate rinse
Product Information
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
Mint
Saccharin Sodium Dihydrate
Water
Product Characteristics
Color BLUE Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50383-720-15 10 CUP, UNIT-DOSE in 1 TRAY contains a CUP, UNIT-DOSE
1 15 mL in 1 CUP, UNIT-DOSE This package is contained within the TRAY (50383-720-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074356 05/07/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074356 05/07/1996
Labeler — Halyard Health (079617666)
Establishment
Name Address ID/FEI Operations
Avent 049316284 LABEL (69697-982), MANUFACTURE (69697-982), PACK (69697-982)
Establishment
Name Address ID/FEI Operations
Elba 108428483 MANUFACTURE (69697-982)
Establishment
Name Address ID/FEI Operations
Hi Tech Pharmacal 101196749 MANUFACTURE (69697-982)

Revised: 01/2016 Halyard Health

Page 2 of 2 1 2

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