Publix 435.000/435aa

Publix 435.000/435aa
SPL v5
SPL
SPL Set ID 14494238-872b-49e2-8bf7-df3844a0a6c8
Route
ORAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Hydrogen Peroxide Poloxamer 407 Saccharin Sodium Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-09-15 Until 2022-10-31

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.02% (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 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 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine® HealthyWhite™ Vibrant Anticavity Fluoride Mouthrinse.

Contains peroxide, which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.

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% (0.01% w/v fluoride ion)

Other Information
  • store at room temperature.
Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

P

Antivavity

Glowing white

Mouthrinse

  • Begins working on contact
  • 5 days to whiter teeth
  • Helps strengthen teeth
  • Kills germs that cause bad breath

*Compare to the ingredients of Listerine ®Healthywhite™ Vibrant Anticavity Fluoride Mouthrinse

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use.

32 FL OZ (1 QT) 946 mL

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 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 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine® HealthyWhite™ Vibrant Anticavity Fluoride Mouthrinse.

Contains peroxide, which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.

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

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

Other Information (Other information)
  • store at room temperature.
Inactive Ingredients (Inactive ingredients)

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

P

Antivavity

Glowing white

Mouthrinse

  • Begins working on contact
  • 5 days to whiter teeth
  • Helps strengthen teeth
  • Kills germs that cause bad breath

*Compare to the ingredients of Listerine ®Healthywhite™ Vibrant Anticavity Fluoride Mouthrinse

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use.

32 FL OZ (1 QT) 946 mL

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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