ORAL ANTIVAVITY- sodium fluoride mouthwash

Oral Antivavity by

Drug Labeling and Warnings

Oral Antivavity by is a Otc medication manufactured, distributed, or labeled by Amazon.Com Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

WARNINGS

Warnings

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 bwtween your teeth for 1 minute 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 witout supervision
• children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurrence.

Sealed with printed neckband for your protection.

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

SEALED WITH PRINTED NECKBAND FOR YOUR PORTECTION 

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

amazon basics

anticavity

fluoride

mouthwash

Alcohol Free

Refreshing Mint Flavor

IMPORTANT: READ DIRECTIONS FOR PROPER USE

33.8 fl oz (1 L)

INGREDIENTS AND APPEARANCE

ORAL ANTIVAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-576
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.41 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-576-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/01/2018

Labeler - Amazon.Com Services LLC (128990418)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72288-576)