SODIUM FLUORIDE RINSE liquid

Drug Labeling and Warnings

Drug Details [pdf]

Tamper Evident Statement

Sealed with printed neckband for your protection.

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

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE RINSE 
sodium fluoride rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69892-971
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EUCALYPTOL (UNII: RV6J6604TK)
SPEARMINT OIL (UNII: C3M81465G5)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
THYMOL (UNII: 3J50XA376E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SORBITOL (UNII: 506T60A25R)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69892-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/20/2026

Labeler - Rockland Cosmetics, Inc. (027966560)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(69892-971)