Heb 163.005/163af

Heb 163.005/163af
SPL v14
SPL
SPL Set ID 87327a36-a314-4daa-83b6-b4bd3e26bba2
Route
ORAL
Published
Effective Date 2025-07-08
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 2010-09-29 Until 2023-12-29

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warnings

For this product

Directions

Adults and children 6 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 6 years of age: consult a dentist or doctor
Disclaimer

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

Questions?

Call 1-888-593-0593

Adverse Reaction

MADE WITH PRIDE AND CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

H-E-B ®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.

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Active Ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Other Information
  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • 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

Principal Display Panel

GREAT NEW FLAVOR

*Compare to Listerine ®Total Care Anticavity Mouthwash

H-E-B ®

Mint

ANTICAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

  • Kills Germs That Cause Bad Breath
  • Helps Prevent Cavities

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 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 6 years of age: consult a dentist or doctor
Disclaimer

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

Questions?

Call 1-888-593-0593

Adverse Reaction (ADVERSE REACTION)

MADE WITH PRIDE AND CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

H-E-B ®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.

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Active Ingredient (Active ingredient)

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Other Information (Other information)
  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • 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)

GREAT NEW FLAVOR

*Compare to Listerine ®Total Care Anticavity Mouthwash

H-E-B ®

Mint

ANTICAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

  • Kills Germs That Cause Bad Breath
  • Helps Prevent Cavities

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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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