ACT Anticavity Fluoride Arctic Blast

Manufacturer
Chattem, Inc.
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:23

Label at a glance#

ProductACT Anticavity Fluoride Arctic Blast
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap hold bottle upright and squeeze. FILL to FILL LINE (10 mL) 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 s...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT® Anticavity™ Fluoride Rinse

Arctic Blast

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% 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 once a day after brushing your teeth with a toothpaste
  • remove cap
  • hold bottle upright and squeeze. FILL to FILL LINE (10 mL)
  • 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

  • do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZERO ALCOHOL
ACT
1X Daily
ANTICAVITY
ARCTIC BLAST
18 fl oz (532 mL)

 

PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL)PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL)PRINCIPAL DISPLAY PANEL ZERO ALCOHOL ACT 1X Daily ANTICAVITY ARCTIC BLAST 18 fl oz (532 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSN4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN4
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBD4
240698sodium fluoride 0.5 MG/ML MouthwashSCD4
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSY4
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSY4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY4

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
41167-0937-2ACT Anticavity Fluoride Arctic Blast532 mL in 1 BOTTLE, PLASTICMOUTHWASH5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0937ACT ANTICAVITY FLUORIDE ARCTIC BLAST (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4Current NDC, Legacy NDC, 1 package rows20250206_2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57.zip

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
41167-093741167-0937-2

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 Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
ndc (package): 41167-0937-2
ndc (product): 41167-0937
ndc11 (package): 41167093702
spl id: 36e783b7-17fc-4f04-a208-8b5f673041a9
spl set id: 2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57

Reported adverse events (FAERS/openFDA)#

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