Anticavity Fluoride Mouthwash

Drug Labeling and Warnings

Drug Details [pdf]

ANTICAVITY FLUORIDE- sodium fluoride mouthwash 
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.

----------

Anticavity Fluoride Mouthwash

Drug Facts

Active ingredient

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

Purpose

Anticavity Fluoride Mouthwash

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 12 years of age in good rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap.

Children under 6 years of age: Consult a dentist or doctor

Other information Store at room temperature. Cold temperature may temporarily cloud this product.

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, poloxamer 407, propylparaben, disodium phosphate, blue 1

This rinse may cause temporary staining to the surface of teeth.

This is not harmful and adequate brushing may prevent its occurrence.

PRINCIPAL DISPLAY PANEL

Alcohol Free

Anticavity Fluoride

MOUTHWASH
Sodium Fluoride Oral Solution
CVS
Health

33.8 FL OZ (1L)

IMPORTANT: Read directions for proper use.

ANTICAVITY FLUORIDE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66923-429
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)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66923-429-15	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/15/2016	12/31/2018

Labeler - Ranir LLC (364567615)

Revised: 11/2019

Document Id: 969f3760-69b2-6ad6-e053-2a95a90a1227

34390-5

Set id: 517efd17-b022-4afc-95b0-9e24cab83616

Version: 3

Effective Time: 20191105