Best Choice 004.002/004ae

Best Choice 004.002/004ae
SPL v18
SPL
SPL Set ID 088b95e6-30fd-4263-9fdc-57cd63385b71
Route
ORAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-29

Description

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributer of Act ®Anticavity Kids Fluoride Rinse.

Adverse Reaction

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

Scan here for more product information.

Call 1-844-292-1112 for more product information.

Active Ingredient

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Other Information

store at room temperature

Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

Best Choice ®

Compare to the active ingredient in Act ®Anticavity Kids Fluoride Rinse*

Children's ANTICAVITY FLUORIDE RINSE

Bubble Gum Flavor

ADA Accepted

American Dental Association

Helps prevent cavities

Helps Prevent Cavities

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

16.9 FL OZ (1.05 PT) 500 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

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributer of Act ®Anticavity Kids Fluoride Rinse.

Adverse Reaction (Adverse reaction)

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

Scan here for more product information.

Call 1-844-292-1112 for more product information.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.2% 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, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (Principal display panel)

Best Choice ®

Compare to the active ingredient in Act ®Anticavity Kids Fluoride Rinse*

Children's ANTICAVITY FLUORIDE RINSE

Bubble Gum Flavor

ADA Accepted

American Dental Association

Helps prevent cavities

Helps Prevent Cavities

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

16.9 FL OZ (1.05 PT) 500 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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