ACT Anticavity Fluoride Kids Spongebob

Manufacturer
Chattem, Inc. | Chattem Plant 3
Effective date
2017-11-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:10:04

Label at a glance#

ProductACT Anticavity Fluoride Kids Spongebob
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 line 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 childre...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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 line 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, sodium benzoate, sodium phosphate, sorbitol, sucralose, water (283-039)

Learn more at www.ACTFLUORIDE .com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
KID”S RINSE BRAND

ACT
®
Ki
ds
Anitcavity
Fluoride Rinse

OCEAN BERRY

nickelodeon

SpongeBOB
SQUAREPANTS

Sodium Fluoride 0.05%

16.9 fl oz (500 mL)

#1 DENTIST RECOMMENDED KID”S RINSE BRAND ACT® Kids Anitcavity Fluoride Rinse OCEAN BERRY nickelodeon SpongeBOB SQUAREPANTS Sodium Fluoride 0.05% 16.9 fl oz (500 mL)#1 DENTIST RECOMMENDED KID”S RINSE BRAND ACT® Kids Anitcavity Fluoride Rinse OCEAN BERRY nickelodeon SpongeBOB SQUAREPANTS Sodium Fluoride 0.05% 16.9 fl oz (500 mL)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W76
FLUORIDE IONACTIVE MOIETYQ80VPU408O6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH6
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P6
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D0349556
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M26
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ46
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY376
SORBITOLINACTIVE INGREDIENT506T60A25R6
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD46
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-093541167-0935-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 363 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37CONCENTRATE / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / SUBCUTANEOUS0.38 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SOLUTION / NASAL1.89 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE CALCIUM DISODIUM ANHYDROUSEDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955INJECTION / INTRAVENOUS23 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37CAPSULE / ORAL36 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, SOLUTION / INTRAMUSCULAR0.14 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRABURSALADJ PHExact identifier — unii candidate
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
d161ecfb-4780-4001-9c14-59537db4785b56efc245-9839-4a11-b89b-5f57539fd0f32010-02-01WarningsExact identifier
spl set id: 56efc245-9839-4a11-b89b-5f57539fd0f3

Reported adverse events (FAERS/openFDA)#

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