Market Basket 971.001/971ab

Market Basket 971.001/971ab
SPL v4
SPL
SPL Set ID 096e6a1d-316b-432a-bf27-70e8a13337cc
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
Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-04
Description

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

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC. 875 East Street Tewksbury, MA 01876 

Medication Information

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC. 875 East Street Tewksbury, MA 01876 

Description

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

Use

aids in the prevention of dental cavities

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily 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 Consumer Inc. distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Other Information
  • store at controlled room temperature 20° - 25°C (68° - 77° F)
  • cold weather may temporarily cloud this product
Active Ingredients

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

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

Principal Display Panel

"MORE FOR YOUR DOLLAR"

MARKET BASKET ®

Compare to Listerine ®Total Care Zero Alcohol Mouthwash*

FLOURIDE

ANTI-CAVITY

MOUTHWASH

Sodium fluoride and Acidulated Phosphate Topical Solution

Fresh Mint

  • Helps strengthen teeth to fight cavities
  • Restores enamel
  • Helps kill bad breath germs
  • Alcohol Free

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For our Protection

1 L (33.8 FL OZ)

Adverse Reactions Section

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876 

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 rinse

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily 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 Consumer Inc. distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Other Information (Other information)
  • store at controlled room temperature 20° - 25°C (68° - 77° F)
  • cold weather may temporarily cloud this product
Active Ingredients

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

Inactive Ingredients (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

"MORE FOR YOUR DOLLAR"

MARKET BASKET ®

Compare to Listerine ®Total Care Zero Alcohol Mouthwash*

FLOURIDE

ANTI-CAVITY

MOUTHWASH

Sodium fluoride and Acidulated Phosphate Topical Solution

Fresh Mint

  • Helps strengthen teeth to fight cavities
  • Restores enamel
  • Helps kill bad breath germs
  • Alcohol Free

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For our Protection

1 L (33.8 FL OZ)

Adverse Reactions Section (Adverse reactions section)

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876 

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: 2026-02-15T12:08:30.667471 · Updated: 2026-03-14T23:12:45.219834