FDA.reportPublic FDA data

ACT Kids Anticavity Fluoride

Manufacturer
Chattem, Inc.
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:24

Label at a glance#

ProductACT Kids Anticavity Fluoride Wild Watermelon
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

a dults 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT® Anticavity Wild Watermelon

Fluoride Rinse

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 accidently swallowed, get medical help or contact 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

  • 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

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACT
Kids
ANTICAVITY
FLUROIDE RINSE
Wild Watermelon
Sugar & Alcohol Free
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

ACT Kids ANTICAVITY FLUROIDE RINSE Wild Watermelon Sugar & Alcohol Free Sodium Fluoride 0.05% 16.9 fl oz (500 mL)ACT Kids ANTICAVITY FLUROIDE RINSE Wild Watermelon Sugar & Alcohol Free Sodium Fluoride 0.05% 16.9 fl oz (500 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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0938-1ACT Kids Anticavity FluorideWild Watermelon500 mL in 1 BOTTLE, DISPENSINGRINSE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0938ACT KIDS ANTICAVITY FLUORIDE WILD WATERMELON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]4Current NDC, Legacy NDC, 1 package rows20250206_8d7faeab-ac70-472a-acbb-de67493718ce.zip

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
41167-093841167-0938-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML · Source PDF

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 Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
ndc (package): 41167-0938-1
ndc (product): 41167-0938
ndc11 (package): 41167093801
spl id: 918037c5-c0c8-41e3-91e6-4882e513e8bd
spl set id: 8d7faeab-ac70-472a-acbb-de67493718ce

Reported adverse events (FAERS/openFDA)#

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