Publix 971.001/971ab

Publix 971.001/971ab
SPL v7
SPL
SPL Set ID f0e84078-499f-4a5a-bcd2-23f57805de86
Route
ORAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol, Unspecified Form Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-08
Description

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

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC. 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811 publix.com PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK SEALED WITH PRINTD NECKBND FOR YOUR PROTECTION Publix

Medication Information

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC. 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811 publix.com PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK SEALED WITH PRINTD NECKBND FOR YOUR PROTECTION Publix

Description

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

Use

aids in the prevention of dental cavities

Warning

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 Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

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

Active Ingredient

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

Other Information
  • store at controlled room temperature 68-77F (20-25C)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Display Panel

P

ANTICAVITY

alcoholfree

MOUTHWASH

Sodium Fluoride & Acidulated Phosphate Topical Solution

Fress mint flavor

  • Restores enamel
  • Helps strengthen teeth to fight cavities
  • Kills bad breath germs
  • Cleans the entire mouth**
  • Freshens breath

*Compare to Listerine ®Total Care Zero Alcohol Anticavity Mouthwash

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

Adverse Reactions Section

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK

SEALED WITH PRINTD NECKBND FOR YOUR PROTECTION

Publix

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 rinse

Warning

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 Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

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

Active Ingredient

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

Other Information (Other information)
  • store at controlled room temperature 68-77F (20-25C)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Display Panel (principal display panel)

P

ANTICAVITY

alcoholfree

MOUTHWASH

Sodium Fluoride & Acidulated Phosphate Topical Solution

Fress mint flavor

  • Restores enamel
  • Helps strengthen teeth to fight cavities
  • Kills bad breath germs
  • Cleans the entire mouth**
  • Freshens breath

*Compare to Listerine ®Total Care Zero Alcohol Anticavity Mouthwash

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

Adverse Reactions Section (Adverse reactions section)

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK

SEALED WITH PRINTD NECKBND FOR YOUR PROTECTION

Publix

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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:33.614636 · Updated: 2026-03-14T23:12:49.502411