Anticavity fluoride rinse — v1

Anticavity fluoride rinse

8 Views

Version

v1

Effective date

September 29, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3ff2de4d-32a1-adb4-e063-6294a90ab429
Set ID
0bb9fb5f-1893-4187-b60b-05319a8fac6a
Application numbers
M021
Product NDCs
79481-0838
Package NDCs
79481-0838-1
Original packager NDCs
—

Names & Manufacturers

Brand names
Anticavity fluoride rinse
Generic names
SODIUM FLUORIDE
Manufacturer names
Meijer Distribution, Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
SODIUM FLUORIDE
Routes
ORAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
8ZYQ1474W7
UPC
0000000000000

Structured Label Sections

Active Ingredient (1)

Sequence 1

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

Sequence 1

ADVERSE REACTIONS OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com
Dosage And Administration (1)

Sequence 1

Directions adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark 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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate
Indications And Usage (1)

Sequence 1

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

Sequence 1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL meijer ® COMPARE TO THERABREATH ® FOR KIDS! WACKY WATERMELON* Kids Anticavity Fluoride Oral Rinse Anticavity Fluoride Rinse IMPORTANT: read directions for proper use. Wonderful Watermelon Strong Cavity Protection Dye, Alcohol & Sugar Free Helps Strengthen Teeth 10 FL OZ (296 mL) image description
Purpose (1)

Sequence 1

Purpose Anticavity
Spl Product Data Elements (1)

Sequence 1

Anticavity fluoride rinse Sodium fluoride WATER GLYCERIN SODIUM BENZOATE POTASSIUM SORBATE XYLITOL CITRIC ACID MONOHYDRATE SUCRALOSE SODIUM CITRATE, UNSPECIFIED FORM SODIUM FLUORIDE FLUORIDE ION
Spl Unclassified Section (2)

Sequence 1

TAMPER EVIDENT STATEMENT SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Sequence 2

Disclaimer *This product is not manufactured or distributed by Church & Dwight Co. Inc., distributor of TheraBreath ® for Kids! Anticavity Fluoride Oral Rinse Wacky Watermelon.
Storage And Handling (1)

Sequence 1

Other information store at room temperature
Warnings (1)

Sequence 1

Warning For this product

OpenFDA raw payload

{'application_number': ['M021'],
 'brand_name': ['Anticavity fluoride rinse'],
 'generic_name': ['SODIUM FLUORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Meijer Distribution, Inc'],
 'package_ndc': ['79481-0838-1'],
 'product_ndc': ['79481-0838'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3ff2de4d-32a1-adb4-e063-6294a90ab429'],
 'spl_set_id': ['0bb9fb5f-1893-4187-b60b-05319a8fac6a'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7'],
 'upc': ['0000000000000']}