ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by The Kroger Co., Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 20⁰ - 25⁰ C (68⁰ - 77⁰ 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 1-800-632-6900

Disclaimer

*LISTERINE  IS A REGISTERED TRADEMARK OF KENVUE, INC.

**WHEN USED 2X DAILY

Adverse Reaction

PROUDLY DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

‡THIS PRODUCT IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING.

QUALITY GUARANTEED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

principal panel display

COMPARE TO THE ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ZERO ALCOHOL

*SEE BACK LABEL

Kroger

6 IN 1 CARE

ZERO

ANTICAVITY MOUTHWASH

ZERO ALCOHOL  LONG-LASTING CAVITY PROTECTION  FLUORIDE

FRESH MINT

KILLS 99.9% OF GERMS†

†THAT CAUSE BAD BREATH

1. 24HR CAVITY PROTECTION**
2. RESTORES ENAMEL
3. STRENGTHENS TEETH
4. FRESHENS BREATH
5. CLEANS WHOLE MOUTH†
6. KILLS BAD BREATH GERMS

QUALITY GUARANTEED

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

33.8 FL OZ (1.05 QT) 1L

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59450-971
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORIC ACID (UNII: E4GA8884NN)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59450-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	11/08/2024

Labeler - The Kroger Co. (006999528)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(59450-971)