b14aa494-840c-44ca-87b7-2d746dab740a — v14

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Version

v14

Effective date

September 30, 2025

Original packager

Sections captured

13

Identifiers

Document ID
4005be4b-5453-a7b6-e063-6294a90adada
Set ID
b14aa494-840c-44ca-87b7-2d746dab740a
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

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Generic names
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Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Adverse Reactions (1)

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Adverse Reaction Like it or let us make it right. That's our quality promise. 855-423-2630 DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908 USA Patent D604,628
Dosage And Administration (1)

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Directions adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste remove cap pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark vigorously swish 10 millilitrs of rinse between your teeth for 1 minute then spit out do not swallow the rinse do not eat or drink for 30 miutes 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 year of age: consult a dentist or doctor
Inactive Ingredient (1)

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Inactive ingredient benzyl alcohol, calcium disodium EDTA, cetylpyridiniun chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Indications And Usage (1)

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Use aids in the prevention of dental cavities
Keep Out Of Reach Of Children (1)

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Keep out of reach of children If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center immediately.
Other Safety Information (1)

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TEP Sealed with printed neckband for your protection
Package Label Principal Display Panel (1)

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Principal panel display NDC 41163-004-77 compare to Act ® Bubblegum Blowout ® Anticavity Fluoride Rinse active ingredient* EQUALINE ® kids anticavity fluoride rinse strong cavity protection helps strengthen teeth does not contain ethyl alcohol bubblegum flavor IMPORTANT: READ DIRECTIONS FOR PROPER USE. 16.9 FL OZ (500 mL) image description image description
Purpose (1)

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Purpose Anticavity rinse
Spl Product Data Elements (1)

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Anticavity Sodium fluoride BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SACCHARIN SODIUM SORBITOL WATER SODIUM FLUORIDE FLUORIDE ION
Spl Unclassified Section (1)

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Disclaimer *This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Bubblegum Blowout ® Anticavity Kids Fluoride Rinse.
Storage And Handling (1)

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Other information store at room temperature
Warnings (1)

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Warnings For this product