Market Basket 213.002/213ae Rev 2

Market Basket 213.002/213ae Rev 2
SPL v5
SPL
SPL Set ID 65abfb4d-3a1e-42df-b343-f270ce60a3bf
Route
ORAL
Published
Effective Date 2025-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Edetate Calcium Disodium Anhydrous Edetate Disodium Anhydrous Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5 Water Sorbitol Menthol Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-25

Description

Sodium fluoride 0.05%  (0.02% w/v fluoride ion)

Purpose

Anticavity rinse


Medication Information

Purpose

Anticavity rinse

Description

Sodium fluoride 0.05%  (0.02% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Warning

for this product

Directiions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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® Anticavity Fluoride Rinse

DISTRIBUTED BY:

Demoulas Super Markets, Inc.

875 East Street, Tewksbury, MA 01876

Active Ingredient

Sodium fluoride 0.05%  (0.02% w/v fluoride ion)

Other Information
  • store at room temperature
Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

Principal Display Panel

Sealed With Printed Necband For Your Protection

"MORE FOR YOUR DOLLAR"

Market Basket®

COMPARE TO ACT®*

Mint Flavor

ANTI-CAVITY

Fluoride Rinse

  • Alcohol free
  • Strong cavity protection
  • Strengthens teeth
  • Freshens breath

IMPORTANT: read directions for proper use.

18 FL OZ (532 mL)

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Warning

for this product

Directiions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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® Anticavity Fluoride Rinse

DISTRIBUTED BY:

Demoulas Super Markets, Inc.

875 East Street, Tewksbury, MA 01876

Active Ingredient (Active ingredient)

Sodium fluoride 0.05%  (0.02% w/v fluoride ion)

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

Principal Display Panel (principal display panel)

Sealed With Printed Necband For Your Protection

"MORE FOR YOUR DOLLAR"

Market Basket®

COMPARE TO ACT®*

Mint Flavor

ANTI-CAVITY

Fluoride Rinse

  • Alcohol free
  • Strong cavity protection
  • Strengthens teeth
  • Freshens breath

IMPORTANT: read directions for proper use.

18 FL OZ (532 mL)

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)