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 Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) 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 controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
• cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

Adverse reactions

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

DSP-TN-21091

DSP-MO-20087

Principal display panel

Sealed With Printed Neckband For Your Protection

Swan ®

ANTICAVITY

Fluoride Rinse

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

eucalyptus mint

• Restores Enamel
• Freshens Breath
• Helps Prevent Cavities
• Helps Strengthen Teeth
• Helps Kill Germs That Cause Bad Breath

Compare Listerine ® Total Care Fresh Mint Anticavity Mouthwash*

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 LITER (1.05 QT) 33.8 FL OZ

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-163
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN (UNII: FST467XS7D)
THYMOL (UNII: 3J50XA376E)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/13/2006

Labeler - Consumer Product Partners, LLC (119091520)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(11344-163)