Heb 435.000/435aa

Heb 435.000/435aa
SPL v16
SPL
SPL Set ID d0a52519-3339-40ea-93e5-78f76d348a4d
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 Alcohol Hydrogen Peroxide Poloxamer 407 Saccharin Sodium Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-21

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B ® SAN ANTONIO, TX 78204 HEB 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


Medication Information

Purpose

Anticavity

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B ® SAN ANTONIO, TX 78204 HEB 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

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 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 Mouthrinse.

Active Ingredient

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

Other Information

store at room temperature (59º-77ºF)

Other Information

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

Inactive Ingredients

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

Principal Display Panel

*Compare to Listerine ®Healthy White™ Vibrant Anticavity Mouthwash

H-E-B ®

Fresh Mint

GLEAMING

WHITE

ANTICAVITY MOUTHRINSE

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

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

IMPORTANT: read directions for proper use.

32 FL OZ (1 QT) 946 mL

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

HEB 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

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 Mouthrinse.

Active Ingredient

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

Other Information (Other information)

store at room temperature (59º-77ºF)

Other Information (other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (principal display panel)

*Compare to Listerine ®Healthy White™ Vibrant Anticavity Mouthwash

H-E-B ®

Fresh Mint

GLEAMING

WHITE

ANTICAVITY MOUTHRINSE

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

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

IMPORTANT: read directions for proper use.

32 FL OZ (1 QT) 946 mL

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

HEB 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

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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