Tamper Evident Statement
Sealed with printed neckband for your protection.
Sodium Fluoride Rinse Liquid
FDA Label NDC 69892-971
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rockland Cosmetics, Inc. for the product Sodium Fluoride Rinse (NDC 69892-971). 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 tamper evident statement, active ingredient, purpose, use, warning, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warning
for this product.
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.
Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL 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
- store at controlled room temperature 20°-25°C (68°–77° F)
- cold weather may temporarily cloud this product
Inactive Ingredients
water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1
Questions Or Comments?
Call 877-757-5005
Disclaimer
*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.
Adverse Reactions
Distributed by: Rockland Cosmetics, Inc.
Hillburn, NY 10931
www.RocklandCosmetics.com
Made in the U.S.A. with U.S. and foreign components.
NSK
New Square Kashrus
Principal Display Panel
COMPARE TO LISTERINE ® ZERO ALCOHOL*
mint'evo
EVOLUTIONIZING ORAL FRESHNESS
FLUORIDE ANTI-CAVITY MOUTHWASH
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
ALCOHOL FREE
HELPS STRENGTHEN TEETH TO FIGHT CAVITIES
FRESHENS BREATH
FRESH MINT
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
1 L (1.05 QT) 33.8 FL OZ
Mm01 (Mm01)
Mm02 (Mm02)
* Please review the disclaimer below.
