Anticavity Fluoride Rinse

Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details

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ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
CVS Pharmacy, Inc

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 Rinse

Active ingredient

Sodium fluoride 0.05% (0.02%w/v fluoride ion)

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters 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

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

other information

  • store at room temperature

Adverse reaction 

Sealed with printed neckband for your protection.

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluorde Rinse.

Distributed by CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com

1-800-shop-CVS

004.002/004AE

principal display panel

CVS

pharmacy

Compare to ACT

Kid's

ANTICAVITY

FLUORIDE RINSE

ALCOHOL FRE

  • Helps prevent cavities

Bubble

Gum

Flavor

IMPORTANT: Read directions for proper use

ADA

Accepted

American

Dental

Association

18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
poloxamer 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/08/2004
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(59779-004)

Revised: 3/2019
 
CVS Pharmacy, Inc


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