Heb 971.001/971ab

Heb 971.001/971ab
SPL v8
SPL
SPL Set ID 8df324a7-9204-40f3-8ddb-1656286d7d4e
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol 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 2021-04-20

Description

Sodium fluoride 0.0% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204 100% GUARANTEE promise If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.


Medication Information

Purpose

Anticavity rinse

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204 100% GUARANTEE promise If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

Description

Sodium fluoride 0.0% (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 miute 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 Consumer Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

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

Questions?

Call 1-888-593-0593

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

Sodium fluoride 0.0% (0.01% w/v fluoride ion)

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

*Compare to Listerine ®Total Care Zero Alcohol

H-E-B ®

Alcohol Free

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION

  • Helps strengthen teeth to fight cavities
  • Restored enamel
  • Kills bad breath germs
  • Cleans the entire mouth**
  • Alcohol Free
  • Fresh Mint

IMPORTANT: read directions for proper use

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions Section

MADE WITH PRIDE AND CARE FOR H-E-B

SAN ANTONIO, TX 78204

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.

You have our word on it.

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 miute 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 Consumer Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

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

Questions?

Call 1-888-593-0593

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

Sodium fluoride 0.0% (0.01% w/v fluoride ion)

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)

*Compare to Listerine ®Total Care Zero Alcohol

H-E-B ®

Alcohol Free

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION

  • Helps strengthen teeth to fight cavities
  • Restored enamel
  • Kills bad breath germs
  • Cleans the entire mouth**
  • Alcohol Free
  • Fresh Mint

IMPORTANT: read directions for proper use

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions Section (Adverse reactions section)

MADE WITH PRIDE AND CARE FOR H-E-B

SAN ANTONIO, TX 78204

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.

You have our word on it.

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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