ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

Active ingredient

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

Purpose

Anticavity 

Use

aids in the prevention of dental cavities

Warnings

for this product

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.

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

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

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

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

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM DIHYDROGEN HYPOPHOSPHATE (UNII: MR6TW8IQ9X)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/29/2024

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11344-004)