Label at a glance#

ProductAnticavity Fluoride Rinse

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Storage and handling

Other informatio n store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Sodium fluoride 0.0221% (0.01% w/v fluoride ion) Anticavity

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

•adults and children 6 years of age and older: use twice a day after brushing your teeth with toothpaste

•remove cap

•pour 10 milliliters (10 mL mark on inside of cap); do not fill about 10 mL mark

•vigorously swish 10 milliliter of rinse between your teeth for 1 minute and then spit out

•do not sallow the rinse

•do not eat or drink 30 minute after rinsing

•instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

•supervise children as necessary until capable of using without supervision

•children under 6 years of age: consult a dentist or doctor

STORAGE AND HANDLING SECTION

Other information store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

INACTIVE INGREDIENT SECTION

Inactive ingredients water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, methylparaben, propylparaben, red 40, green 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ALCOHOL FREE

ANTIVACITY

Fluoride Rinse

berry

•Kills Germs that Cause Bad Breath

•Helps Prevent Cavities

•See proof in Your Sink of a Cleaner Mouth! Contains Ingredients that Tint Food Particles.

16.9 FL OZ (500 mL)

IMPORTANT: Read directions for proper use.

image of principal display panel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1038904	Sodium fluoride (Mouthwash)	sodium fluoride 0.221 MG/ML Mouthwash	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0869-0893-77	2020-05-22	C162847	48780-1	9d75b9d0-23ec-f424-e053-dadaa90a57ce	Drug Facts
0869-0893-77	2020-01-31	C162847	48780-1	9d75b9d0-23ec-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Anticavity Fluoride Rinse
Anticavity Fluoride
SODIUM FLUORIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0869-0893	0869-0893-77

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB

Source Document#

Source XML

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
4787ebc4-6c49-420a-937f-132774d9d9d2			32a05a99-1073-4795-9c0f-93d8e2d5751d	2020-05-22	Warnings	Exact identifier spl set id: 32a05a99-1073-4795-9c0f-93d8e2d5751d

Reported adverse events (FAERS/openFDA)#

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

Anticavity Fluoride Rinse