Harris Teeter 213.002/213ae Rev 2

Harris Teeter 213.002/213ae Rev 2
SPL v4
SPL
SPL Set ID f759e9e4-6de2-4b80-903b-e67c06e36295
Route
ORAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-05-14

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warning

for this product

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash.

Directions 
  • 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 inside of cap); do not fill above 10 ML mark
  • vigorously swish 10 milliliters 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
Questions? 

Call 1-888-593-0593

Adverse Reaction

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Active Ingredient

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

Other Information
  • store at room temperature
Inactve Ingredients

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

Principal Panel Display

Sealed with printed neckband for your protection

*Compare to Act ®Anticavity Fluoride Mouthwash*

Harris Teeter™

MINT

Anticavity

Fluoride

Mouth Rinse

  • Strong cavity protection
  • Alcohol free

INPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (1.12 PT) 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

Warning

for this product

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash.

Directions 
  • 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 inside of cap); do not fill above 10 ML mark
  • vigorously swish 10 milliliters 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
Questions? 

Call 1-888-593-0593

Adverse Reaction (ADVERSE REACTION)

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Active Ingredient (Active ingredient)

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

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

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

Principal Panel Display

Sealed with printed neckband for your protection

*Compare to Act ®Anticavity Fluoride Mouthwash*

Harris Teeter™

MINT

Anticavity

Fluoride

Mouth Rinse

  • Strong cavity protection
  • Alcohol free

INPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (1.12 PT) 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

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