Alcohol-Free Anticavity — v14

Alcohol-Free Anticavity

4 Views

Version

v14

Effective date

September 24, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3f8eef47-ebf9-4203-e063-6394a90acdfa
Set ID
c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea
Application numbers
M021
Product NDCs
41250-482
Package NDCs
41250-482-86
Original packager NDCs
—

Names & Manufacturers

Brand names
Alcohol-Free Anticavity
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
313029
UNII
8ZYQ1474W7
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Sodium fluoride 0.02% (0.01 w/v fluoride ion)
Adverse Reactions (1)

Sequence 1

Adverse Reaction DISTRIBUTED BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544 www.meijer.com OUR QUALITY GUARANTEE WWW.MEIJER.COM/SATISFACTION The Meijer Family
Dosage And Administration (1)

Sequence 1

Directions Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) 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, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3
Indications And Usage (1)

Sequence 1

Use aids in the preveiontion 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, get medical help or contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Package Label Principal Display Panel (1)

Sequence 1

Principal display panel NDC 41250-482-86 meijer ® *COMPARE TO CREST ® PRO-HEALTH ® ANTICAVITY FLUORIDE MOUTHWASH ACTIVE INGREDIENT* ANTICAVITY Fluoride Rinse ALCOHOL FREE VIOLET MINT 6 Benefits: Kills bad breath germs Helps prevent cavities Helps strengthen enamel Cleans teeth** Freshens breath No alcohol burn IMPORTANT: Read directions for proper use. 1 L (1.05 QT) 33.8 FL OZ image description image description
Purpose (1)

Sequence 1

Purpose Anticavity
Questions (1)

Sequence 1

Questions? 1-888-593-0593
Spl Product Data Elements (1)

Sequence 1

Alcohol-Free Anticavity Sodium fluoride WATER GLYCERIN CETYLPYRIDINIUM CHLORIDE CINNAMALDEHYDE SACCHARIN SODIUM PHOSPHORIC ACID SODIUM BENZOATE SUCRALOSE POLOXAMER 407 BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PROPYLENE GLYCOL D&C RED NO. 33 FD&C GREEN NO. 3 SODIUM FLUORIDE FLUORIDE ION
Spl Unclassified Section (2)

Sequence 1

Claim FOR BETTER ORAL HYGIENE AND FRESHER BREATH

Sequence 2

Disclaimers *Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® Advanced Fluoride Mouthwash Enamel Care Alcohol Free. **This product is not intended to replace brushing or flossing.
Warnings (1)

Sequence 1

Warnings for this product
Warnings And Cautions (1)

Sequence 1

Warnings for CPC Containing Products This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

OpenFDA raw payload

{'application_number': ['M021'],
 'brand_name': ['Alcohol-Free Anticavity'],
 'generic_name': ['SODIUM FLUORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Meijer Distribution, Inc'],
 'package_ndc': ['41250-482-86'],
 'product_ndc': ['41250-482'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['313029'],
 'spl_id': ['3f8eef47-ebf9-4203-e063-6394a90acdfa'],
 'spl_set_id': ['c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7']}