Swan 004 004.002/004ae

Swan 004 004.002/004ae
SPL v3
SPL
SPL Set ID c71d4064-f938-477b-9346-eb38be65390d
Route
ORAL
Published
Effective Date 2025-03-11
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 Cetylpyridinium Chloride Edetate Disodium Disodium Dihydrogen Hypophosphate 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 2024-02-29

Description

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

Purpose

Anticavity 


Medication Information

Purpose

Anticavity 

Description

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

Use

aids in the prevention of dental cavities

Claims

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

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., distributor of Act ® Bubblegum Blowout ®Anticavity Fluoride Rinse.

Adverse Reaction

Distributed by: Consumer Product Partners, LLC, 

St. Louis, MO 63114, 1-888-593-0593

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, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

Sealed With Printed Neckband For Your Protection

SWAN ®

KIDS 

ANTICAVITY 

ALCOHOL FREE 

FLUORIDE RINSE

bubble gum 

FLAVOR

Strong Cavity Protection

Compare to the active ingredient of Act ®Bubblegum Blowout ®Anticavity Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

ADA Accepted

American Dental Association

Helps prevent cavities

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

Claims

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

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., distributor of Act ® Bubblegum Blowout ®Anticavity Fluoride Rinse.

Adverse Reaction (Adverse reaction)

Distributed by: Consumer Product Partners, LLC, 

St. Louis, MO 63114, 1-888-593-0593

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, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (Principal display panel)

Sealed With Printed Neckband For Your Protection

SWAN ®

KIDS 

ANTICAVITY 

ALCOHOL FREE 

FLUORIDE RINSE

bubble gum 

FLAVOR

Strong Cavity Protection

Compare to the active ingredient of Act ®Bubblegum Blowout ®Anticavity Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

ADA Accepted

American Dental Association

Helps prevent cavities

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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