Market Basket 581.000/581ab

Market Basket 581.000/581ab
SPL v4
SPL
SPL Set ID 2f5d3c75-1a11-47e1-b297-e2302177efe7
Route
ORAL
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Sorbitol Poloxamer 407 Propylene Glycol Sodium Benzoate Sodium Phosphate Polysorbate 20 Saccharin Sodium Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Anhydrous Fd&c Blue No. 1 Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-05

Description

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Use

Aids in the prevention of dental cavities

Claims

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Warning

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
Adverse Reaction

*This product is not manufactured or distributed by Chattem Inc., distributor of Act ®Restoring Anticavity Mouthwash Cool Mint

DSP-TN-21091

DSP-MO-20087

DISTRIBUTED BY 

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

Active Ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Inactive Ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Principal Panel Display

Sealed With Printed Neckband For Your Protection

MARKET BASKET ®

"MORE FOR YOUR DOLLAR"

Compare to Act ®Restoring Anticavity Fluoride Mouthwash*

Restoring Anticavity 

Fluoride Mouthwash

ANTICAVITY MOUTHWASH

Refreshing Mint

Restores enamel

Helps avoid tooth decay

Helps remineralize soft spots

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)

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

Claims

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Purpose

Anticavity

Warning

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
Adverse Reaction (Adverse reaction)

*This product is not manufactured or distributed by Chattem Inc., distributor of Act ®Restoring Anticavity Mouthwash Cool Mint

DSP-TN-21091

DSP-MO-20087

DISTRIBUTED BY 

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

Active Ingredient (Active ingredient)

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Principal Panel Display

Sealed With Printed Neckband For Your Protection

MARKET BASKET ®

"MORE FOR YOUR DOLLAR"

Compare to Act ®Restoring Anticavity Fluoride Mouthwash*

Restoring Anticavity 

Fluoride Mouthwash

ANTICAVITY MOUTHWASH

Refreshing Mint

Restores enamel

Helps avoid tooth decay

Helps remineralize soft spots

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)

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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