Anticavity Rinse

Manufacturer
DZA Brands | Vi Jon
Effective date
2019-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:31:13

Label at a glance#

ProductAnticavity Rinse
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

adults and children 6 year of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing h...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Purpose

OTC - PURPOSE SECTION

Anticavity Rinse

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

for this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 year of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes 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 year of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse reactions

ADVERSE REACTIONS SECTION

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Fluoride Rinse.

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 04074

For questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package.

Money back satisfaction gurantee

004.002/004AAE

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healty

accents

children's

anticavity

fluoride rinse

strong cavity protection helps strengthen teeth

alcohol free

compare to the active ingredients of Act

bubblegum flavor

IMPORTANT: READ DIRECTION FOR PROPER USE

18 FL OZ (532 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55316-00455316-004-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00191cb7-094f-4fd2-9cff-dda3a7f29450cd331f1a-5f9e-4251-8314-2141d8eb95c92019-02-12Warnings, Adverse reactionsExact identifier
spl id: 00191cb7-094f-4fd2-9cff-dda3a7f29450
spl set id: cd331f1a-5f9e-4251-8314-2141d8eb95c9

Reported adverse events (FAERS/openFDA)#

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