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

Purpose

Anticavity

Description

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


Medication Information

Warnings

for this product

Purpose

Anticavity

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
Other Information
  • store at room temperature.
Inactive Ingredients

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

Description

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

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

Use

Aids in the prevention of dental cavities

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)

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 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
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

Use

Aids in the prevention of dental cavities

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)

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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