ANTICAVITY RINSE FLUORIDE RINSE- anticavity rinse mouthwash
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts 344

Active ingrident

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticvity

Use

aids in the prevention of dental cavities

Warnings

For this productIf more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center right away.

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center right away.

Directions

adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 mL mare 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.

Other information

store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

Inactive ingredients

water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpridinium chloride, disodium phosphate, methylparaben, propylparaben, yellow 6, blue1

Adverse Reactions Section

DISTRIBUTED BY: American Sales Company

4201 Waldern AVenue Lancaster, NY 14086

Quality guaranteed or your money back

principal display panel

Compare to Listerine Smart Rinse

Care One

FOR KIDS

ANTICAVITY

FLUORIDE RINSE

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

Kills germs that cause bad breath
Helps prevent cavities
Alcohol free

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

image description

ANTICAVITY RINSE FLUORIDE RINSE
anticavity rinse mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-344
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	Sodium Fluoride	.0221 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-344-77	0.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2009	02/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/05/2009	02/20/2020

Labeler - American Sales Company (809183973)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(41520-344)

Revised: 3/2020

Document Id: 4fb0e6ca-458c-453d-9238-0dd1bd0f0d07

Set id: 39d5f994-070f-4099-84e5-d8b673b4af27

Version: 29

Effective Time: 20200309

American Sales Company