Market Basket 163.005/163af

Market Basket 163.005/163af
SPL v16
SPL
SPL Set ID c28c3475-efbb-4099-83ab-ab91bac9dfc3
Route
ORAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-05-13

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 12 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 Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC

875 EAST STREET

TEWKSBURY, MA 01876

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Active Ingredient

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

Other Information

• store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)

• cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Panel Display

"More for your Dollar"

MARKET BASKET ®

Compare to Listerine ®Total Care Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

• Helps prevent cavities

• Helps strengthen teeth

• Helps kill germs that cause bad breath

• Freshens breath

• Restores enamel

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For Your Protection

1 L (33.8 FL OZ)

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 12 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 Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC

875 EAST STREET

TEWKSBURY, MA 01876

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Active Ingredient

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

Other Information (Other information)

• store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)

• cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Panel Display (principal panel display)

"More for your Dollar"

MARKET BASKET ®

Compare to Listerine ®Total Care Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

• Helps prevent cavities

• Helps strengthen teeth

• Helps kill germs that cause bad breath

• Freshens breath

• Restores enamel

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For Your Protection

1 L (33.8 FL OZ)

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

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