Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 41163-213

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Anticavity Fluoride Rinse (NDC 41163-213). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredientSodium fluoride 0.05% (0.02% w/v fluoride ion)

Otc - Purpose

PurposeAnticavity rinse

Indications & Usage

Use aids in the prevention of dental cavities

Warnings

Warning

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

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 the inside of cap); do not fill above the 10 mL mark• vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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

Storage And Handling

Other information • store at room temperature

Inactive Ingredient

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride,  disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

Other

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

Adverse Reactions

DISTRIBUTED BY: SUPERVALU INC.EDEN PRAIRIE, MN 55344 USAPRODUCT OF USECONTACT US AT 1-877-932-7948, ORwww.supervalu-ourownbrands.com

Package Label.Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIONequalinecompare toACTalcohol freeanticavity fluoride rinse•helps prevent cavities•strengthens teeth•freshens breathIMPORTANT: READ DIRECTINS FOR PROPER USEmint18 FL OZ(532 mL)

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