ACT Restoring Anticavity Fluoride Mint Burst

Manufacturer
Chattem, Inc.
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:08:04

Label at a glance#

ProductACT Restoring Anticavity Fluoride Mint Burst
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

a dults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters into cap (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 go...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT® Restoring™ Mint Burst

Anticavity Fluoride Rinse

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters into cap (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 years of age: consult a dentist or doctor

Other information

SPL UNCLASSIFIED SECTION

  • contains FD&C yellow no. 5 (tartrazine) as a color additive
  • do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
BRAND FOR STRENGTHENING ENAMEL
ACT
RESTORING
ANTICAVITY FLUORIDE MOUTHWASH
MINT BURST
33.8 oz (1 L)

#1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)#1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSN8
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN8
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBD8
313029sodium fluoride 0.2 MG/ML MouthwashSCD8
1044540ACT Braces Care 0.02 % MouthwashSY8
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSY8
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSY8
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY8
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0978-1ACT Restoring Anticavity Fluoride Mint Burst30 mL in 1 BOTTLE, PLASTICMOUTHWASH308
41167-0978-3ACT Restoring Anticavity Fluoride Mint Burst1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10008
41167-0978-6ACT Restoring Anticavity Fluoride Mint Burst1250 mL in 1 BOTTLE, PLASTICMOUTHWASH12508

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-097841167-0978-3, 41167-0978-6, 41167-0978-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
ndc (package): 41167-0978-1
ndc (package): 41167-0978-3
ndc (package): 41167-0978-6
ndc (product): 41167-0978
ndc11 (package): 41167097806
ndc11 (package): 41167097801
ndc11 (package): 41167097803
spl id: d930bfa0-e3cb-459a-a6c9-e99ac02ece1d
spl set id: 0c7ede82-3b28-40ae-8dfd-cec58825f938

Reported adverse events (FAERS/openFDA)#

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