Antiplaque Solution

Manufacturer: Sage Products LLC
Effective date: 2026-06-29
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: monthly-update
Hydrated at: 2026-07-17 21:36:59

Label at a glance#

ProductAntiplaque solution

Active ingredientCETYLPYRIDINIUM CHLORIDE

Label structure8 sections

Indications and uses

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

Dosage and administration

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...

Contacts and useful links#

PhoneLabel contact800-323-2220

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

ANTIPLAQUE:
Cetylpyridinium chloride .05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/antiplaque

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Call toll-free 800-323-2220

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53462-275-60	2022-02-22	C162847	48780-1	d6a99b39-9e19-a426-e053-dadaa90af4c2	Antiplaque Solution
53462-275-60	2022-02-22	C162847	48780-1	d6a99b39-9e19-a426-e053-dadaa90af4c2	Antiplaque Solution
53462-275-60	2022-01-28	C162847	48780-1	d6a99b39-9e19-a426-e053-dadaa90af4c2	Antiplaque Solution
53462-275-60	2022-01-28	C162847	48780-1	d6a99b39-9e19-a426-e053-dadaa90af4c2	Antiplaque Solution

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
cetylpyridinium chloride	ACTIVE INGREDIENT	D9OM4SK49P	1
cetylpyridinium	ACTIVE MOIETY	CUB7JI0JV3	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
peppermint	INACTIVE INGREDIENT	V95R5KMY2B	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Antiplaque solution
CETYLPYRIDINIUM CHLORIDE
WATER
SORBITOL
PEPPERMINT
POTASSIUM SORBATE
FD&C BLUE NO. 1
POLYSORBATE 80
POLYSORBATE 20
CITRIC ACID MONOHYDRATE
CETYLPYRIDINIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53462-275	53462-275-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
PEPPERMINT	V95R5KMY2B	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
13	2025-12-08	full-release	2026-06-01 01:21:20

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 256 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		5 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 56 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 38 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 56 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 56 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 56 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		5 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 156 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 156 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	Warnings	Exact identifier ndc (package): 53462-275-60 ndc (product): 53462-275 ndc11 (package): 53462027560 spl id: 5568ec99-5769-624a-e063-6294a90a7149 spl set id: 881d4d08-4b45-486a-93af-18c0e00a5b0e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.