Complete Health Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details [pdf]

COMPLETE HEALTH ANTICAVITY FLUORIDE FRESH MINT- sodium fluoride rinse 
Ranir LLC

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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Complete Health Anticavity Fluoride Rinse

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

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 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 

In some cases, rinses may cause staining to teeth. This is not permanent or harmful, and may be prevented by adequate brushing or removed at your next dental visit.

Store below 25° C (77° F)

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, disodium phosphate, red #33, green #3

Distributed by: Ranir, LLC
4701 East Paris Avenue SE
Grand Rapids, MI 49512
www.ranir.com       Made in Canada

PRINCIPAL DISPLAY PANEL

Alcohol Free
Complete Health ™
Anticavity Fluoride Rinse
Total Protection with Fluoride ∙
Strengthens Enamel for a Healthier Mouth
*Compare to Crest ® Pro-Health ™ Complete Anticavity Fluoride Rinse

HELPS PREVENT CAVITIES
REBUILDS ENAMEL
KILLS BAD BREATH GERMS
CLEANS TEETH & GUMS
NO ALCOHOL BURN
FRESHENS BREATH

FRESH MINT

1 L (33.8 FL OZ)

COMPLETE HEALTH ANTICAVITY FLUORIDE  FRESH MINT
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66923-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0219 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66923-104-15	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/31/2015	12/31/2018

Labeler - Ranir LLC (364567615)

Revised: 11/2019

Document Id: 969f3760-69bd-6ad6-e053-2a95a90a1227

34390-5

Set id: c63f0719-940f-4f6a-aaff-cf64c0ef7eff

Version: 2

Effective Time: 20191105