publix 163.005/163af

publix 163.005/163af
SPL v14
SPL
SPL Set ID cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb
Route
oral
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (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 active Since 2011-07-20

Purpose

Anticavity

Description

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


Medication Information

Warnings

for this product

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with 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 12 years of age: consult a dentist or doctor
Other Information
  • store at room temperature 
  • 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

Description

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

Principal Display Panel

P

ANTICAVITY

EUCALYPTUS MINT

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that cause bad breath

*Compare to the active ingredient OF Listerine ®Total Care™ Anticavity Fresh Mint Mouthwash

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

33.8 FL OZ (1.05 QT) 1 L

Use

aids in the prevention of dental cavities

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care™ Anticavity Fresh Mint Mouthwash.

Adverse Reaction

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

PUBLIX ®

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient

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

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

Warnings

for this product

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with 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 12 years of age: consult a dentist or doctor
Other Information (Other information)
  • store at room temperature 
  • 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)

P

ANTICAVITY

EUCALYPTUS MINT

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that cause bad breath

*Compare to the active ingredient OF Listerine ®Total Care™ Anticavity Fresh Mint Mouthwash

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

33.8 FL OZ (1.05 QT) 1 L

Use

aids in the prevention of dental cavities

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care™ Anticavity Fresh Mint Mouthwash.

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

PUBLIX ®

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient (Active ingredient)

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

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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