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Market Basket 435.000/435aa
SPL v14
SPL
SPL Set ID 32faf47d-b64f-4454-9f14-51503504c6b5
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Alcohol Hydrogen Peroxide Water Poloxamer 407 Saccharin Sodium Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-29
Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC. 875 East Street Tewksbury, MA 01876 DSP-TN-15000 DSP-MO34 SDS-TN-15012

Medication Information

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876

DSP-TN-15000

DSP-MO34

SDS-TN-15012

Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use twice a day 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse.

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information
  • store at room temperature (59º-77ºF)
Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

"MORE FOR YOUR DOLLAR"

MARKET BASKET ®

Compare to Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse*

GLOWING WHITE

ANTICAVITY

MOUTHRINSE

Fresh Mint

Begins working on contact

5 days to whiter teeth

Helps strengthen teeth

Kills germs that cause bad breath

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use

32 FL OZ (946 mL)

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.

Structured Label Content

Use

Aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use twice a day 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse.

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Adverse Reactions

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876

DSP-TN-15000

DSP-MO34

SDS-TN-15012

Other Information (Other information)
  • store at room temperature (59º-77ºF)
Inactive Ingredients (Inactive ingredients)

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel (principal display panel)

"MORE FOR YOUR DOLLAR"

MARKET BASKET ®

Compare to Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse*

GLOWING WHITE

ANTICAVITY

MOUTHRINSE

Fresh Mint

Begins working on contact

5 days to whiter teeth

Helps strengthen teeth

Kills germs that cause bad breath

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use

32 FL OZ (946 mL)

Keep Out of Reach of Children. (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:30.694850 · Updated: 2026-03-14T23:12:46.294226