Heb 004.002/004ae

Heb 004.002/004ae
SPL v13
SPL
SPL Set ID 51ddc81b-1c90-4998-b538-6761ac113437
Route
ORAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-02-25

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Purpose

Anticavity Rinse


Medication Information

Purpose

Anticavity Rinse

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions
  • adults and children 6 year of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark
  • vigorously swish 10 milliliters 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 year of age: consult a dentist or doctor

Adverse Reaction

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. 

US ONLY

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.com

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Other Information
  • store at room temperature
Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

ADA Accepted

American Dental Association

Helps prevent cavities

Sealed with printed neckband for your protection

Kids ages 6+

H-E-B ®

BUBBLEGUM

Anticavity

Fluoride Mouthwash

Helps prevent cavities

IMPORTANT: read directions for proper use

18 FL OZ (1.13 PT) 532 mL

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity Rinse

Warnings

for this product

Directions
  • adults and children 6 year of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark
  • vigorously swish 10 milliliters 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 year of age: consult a dentist or doctor

Adverse Reaction (ADVERSE REACTION)

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. 

US ONLY

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.com

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)        

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (Principal display panel)

ADA Accepted

American Dental Association

Helps prevent cavities

Sealed with printed neckband for your protection

Kids ages 6+

H-E-B ®

BUBBLEGUM

Anticavity

Fluoride Mouthwash

Helps prevent cavities

IMPORTANT: read directions for proper use

18 FL OZ (1.13 PT) 532 mL

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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