ACT Anticavity Fluoride Rinse Kids Groovy Grape

Manufacturer
Chattem, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:32:11

Label at a glance#

ProductACT Anticavity Fluoride Kids Groovy Grape
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 ■ inst...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT

Anticavity Kids Rinse Groovy Grape 0.05%

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 RINSE
GROOVY GRAPE
16.9 fl oz (500 mL)

ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL)ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSN6
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN6
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBD6
240698sodium fluoride 0.5 MG/ML MouthwashSCD6
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSY6
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSY6
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix885997act-anticavity-fluoride-rinse-kids-groovy-grape-01.jpg
Data codeData Matrix885998act-anticavity-fluoride-rinse-kids-groovy-grape-01.jpg

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
41167-0945-0ACT Anticavity Fluoride Kids Groovy Grape500 mL in 1 BOTTLERINSE5006

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
41167-094541167-0945-0

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 Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
ndc (package): 41167-0945-0
ndc (product): 41167-0945
ndc11 (package): 41167094500
spl id: 99084e0e-deca-420d-aa5d-e0347b8296c5
spl set id: cd167c0b-2086-4204-b0ac-90df404bd4bb

Reported adverse events (FAERS/openFDA)#

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