ANTIPLAQUE SOLUTION- cetylpyridinium chloride mouthwash

Antiplaque solution by

Drug Labeling and Warnings

Antiplaque solution by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

ANTIPLAQUE:
Cetylpyridinium chloride .05%

Purpose

Antigingivitis/antiplaque

Uses

Aids in the removal and prevention of plaque that leads to gingivitis.

Warnings

Stop use and ask a dentist if:

• Gingivitis, bleeding or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth.  These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Remove Mouth Moisturizer and Applicator Swab.
• Attach Toothbrush to suction line.
• Clean teeth and oral cavity for approximately one minute.
• To suction, place thumb over port.
• To clear tubing, rinse with sterile saline or appropriate solution.
• Discard Toothbrush.  Reattach Covered Yankauer to suction line.
• Place Mouth Moisturizer on Applicator Swab.
• Apply as needed to lips and inside mouth.

• Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
• Children ages 6 to 12 years: supervise use.
• Children under 6 years of age: do not use.
• Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
• Ensure foam is intact after use. If not, remove any particles from oral cavity.

Inactive ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1

Questions

 Call toll-free 800-323-2220

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-275
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-275-60	7 mL in 1 PACKET; Type 0: Not a Combination Product	01/09/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/09/2009

Labeler - Sage Products LLC (054326178)