ANTICAVITY FLUORIDE- sodium fluoride mouthwash 
CVS Pharmacy

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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Anticavity Fluoride Mouthwash

Drug Facts

Active ingredient

Sodium Fluoride 0.02% (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 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

Anticavity Fluoride
Mouthwash
Sodium Fluoride Oral Solution
Minty Fresh
33.8 FL OZ (1 L)

PRINCIPAL DISPLAY PANEL
Anticavity Fluoride
Mouthwash
Sodium Fluoride Oral Solution
Minty Fresh
33.8 FL OZ (1 L)

ANTICAVITY FLUORIDE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-429
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-429-151000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/30/2017
Labeler - CVS Pharmacy (062312574)

Revised: 1/2017
Document Id: 76c1af8f-8836-4bfe-9755-4c27964b6841
Set id: 80950a92-8332-4005-bea0-cff62b3a59fa
Version: 1
Effective Time: 20170130
 
CVS Pharmacy