FDA.reportPublic FDA data

ACT Kids Anticavity Fluoride Fruit Punch

Manufacturer
Chattem, Inc.
Effective date
2015-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:25

Label at a glance#

ProductACT Kids Anticavity Fluoride Fruit Punch
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 pour out. Only the correct 10 milliliters dose will pour out. 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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
  • pour out. Only the correct 10 milliliters dose will pour out.
  • 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

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Act Kids
Anticavity Fluoride
16.9 fl oz (500 mL)

PRINCIPAL DISPLAY PANEL Act Kids Anticavity Fluoride 16.9 fl oz (500 mL)PRINCIPAL DISPLAY PANEL Act Kids Anticavity Fluoride 16.9 fl oz (500 mL)
PRINCIPAL DISPLAY PANEL Act Kids Anticavity Fluoride 16.9 fl oz (500 mL)PRINCIPAL DISPLAY PANEL Act Kids Anticavity Fluoride 16.9 fl oz (500 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSN1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBD1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSY1
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSY1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41167-0936-52020-01-31C16284748780-19d75b9d0-d6c0-f424-e053-dadaa90a57ceACT Kids Anticavity Fluoride Rinse Fruit Punch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0936-5ACT Kids Anticavity Fluoride Fruit Punch500 mL in 1 BOTTLE, DISPENSINGRINSE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0936ACT KIDS ANTICAVITY FLUORIDE FRUIT PUNCH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]1Legacy NDC, 1 package rows20151218_f21a6e6f-e1a0-4520-b29e-beaeb2f6dd1f.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
41167-093641167-0936-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
BENZYL ALCOHOLLKG8494WBHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT

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
4bf8725e-7267-42c8-8d2b-845842c1ff18f21a6e6f-e1a0-4520-b29e-beaeb2f6dd1f2015-12-18WarningsExact identifier
spl id: 4bf8725e-7267-42c8-8d2b-845842c1ff18
spl set id: f21a6e6f-e1a0-4520-b29e-beaeb2f6dd1f

Reported adverse events (FAERS/openFDA)#

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