Mountain Falls 435.000-435AA Glowing White Anticavity Mouthrinse

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTICAVITY- sodium fluoride mouthwash 
Vi-Jon, LLC

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Mountain Falls 435.000-435AA Glowing White Anticavity Mouthrinse

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warning

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 a day 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

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

Rear Label Text

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of LIsterine Healthy White Vibrant Anticavity Mouthrinse

Manufactured by Vi-Jon, Inc. St. Louis, MO 63114

Questions or comments?  1-888-593-0593

Made in teh USA with US and foreign parts.

DSP-TN-1500 DSP-MO-34

principal display panel

mountain falls

Compare to Listerine

helps strengthen teeth

kills germs that cause bad breath

begins working on contact

5 days to whiter teeth

glowing white

anticavity

mouthwash

fresh mint

946 mL (32 FL OZ)

IMPORTANT: READ DIRECTIONS FOR PROPER USE

ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0435
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0435-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/09/2015	11/30/2019
2	NDC: 0869-0435-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/09/2015	02/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/09/2015	02/25/2020

Labeler - Vi-Jon, LLC (088520668)

Registrant - Vi-Jon, LLC (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(0869-0435)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(0869-0435)

Revised: 2/2024

Document Id: 106e1549-ae86-fe78-e063-6294a90a97f2

34390-5

Set id: d4ee5bf3-569c-458b-8759-93cd083ebd5d

Version: 15

Effective Time: 20240202