Cvs 163.005/163af-ag

Cvs 163.005/163af-ag
SPL v16
SPL
SPL Set ID b2f7490c-e2af-49df-b054-70fb4815f729
Route
ORAL
Published
Effective Date 2026-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-09-15 Until 2015-06-13

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warnings

for this product

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 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
Disclaimers

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Anticavity Mouthwash.

†This product is not intended to replace brushing or flossing.

Adverse Reaction

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2026 CVS/pharmacy

CVS.com 1-800-SHOP CVS

100% Money Back Guaranteed.

CVS.com/returnpolicy

DSP-TN-21091

DSP-MO-20087

Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Active Ingredient

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

Other Information
  • store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

Sealed with printed neckband for your protection.

IMPORTANT: Read directions for proper use.

CVS™

Anticavity Fluoride Mouthwash

Fresh Mint Flavor

Compare to Listerine ®Total Care Anticavity Mouthwash*

6 Benefits: Restores enamel,

Helps prevent cavities,

Cleans entire mouth,†

Kills bad breath germs,

Strengthens teeth,

Freshens breath

1 L (1.05 QT) 33.8 FL OZ

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.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

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 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
Disclaimers

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Anticavity Mouthwash.

†This product is not intended to replace brushing or flossing.

Adverse Reaction (ADVERSE REACTION)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2026 CVS/pharmacy

CVS.com 1-800-SHOP CVS

100% Money Back Guaranteed.

CVS.com/returnpolicy

DSP-TN-21091

DSP-MO-20087

Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Active Ingredient

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

Other Information (Other information)
  • store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection.

IMPORTANT: Read directions for proper use.

CVS™

Anticavity Fluoride Mouthwash

Fresh Mint Flavor

Compare to Listerine ®Total Care Anticavity Mouthwash*

6 Benefits: Restores enamel,

Helps prevent cavities,

Cleans entire mouth,†

Kills bad breath germs,

Strengthens teeth,

Freshens breath

1 L (1.05 QT) 33.8 FL OZ

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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