Equate 004.002/004ae

Equate 004.002/004ae
SPL v23
SPL
SPL Set ID 3beb65e4-ae8e-4e51-b9ba-181cbec41eff
Route
ORAL
Published
Effective Date 2025-02-28
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 2004-04-06

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 year of age and older: 

  • use once a day after brushing your teeth with a toothpaste
  • 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

Disclaimer

Made in the USA 

with domestic and imported ingredients

Factory Certified

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks ACT® {and} Bubblegum Blow Out® Anticavity Kids Fluoride Rinse.

Discard Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Adverse Reaction

Distributed by: Walmart Inc.,

Bentonville, AR 72716 

Satisfaction guaranteed - for questions or comments please call 1-888-287-1915

Active Ingredient

Sodium Fluoride 0.05% (0.2% 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

NDC: 49035-004-44

KIDS

equate™

Compare to ACT ® Bubblegum Blowout ® Anticavity Kids Fluoride Rinse active ingredient*

BUBBLE GUM FLAVOR

Kids Anticavity Fluoride Rinse

Strong cavity protection

Helps strengthen teeth

ADA Accepted

American Dental Assoication

  • Helps prevent cavities

ALCOHOL FREE

IMPORTANT: Read directions for proper use.

18 FL OZ (1.12 PT) 532 mL

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, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

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
  • 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

Disclaimer

Made in the USA 

with domestic and imported ingredients

Factory Certified

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks ACT® {and} Bubblegum Blow Out® Anticavity Kids Fluoride Rinse.

Discard Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Adverse Reaction (Adverse reaction)

Distributed by: Walmart Inc.,

Bentonville, AR 72716 

Satisfaction guaranteed - for questions or comments please call 1-888-287-1915

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.2% 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)

NDC: 49035-004-44

KIDS

equate™

Compare to ACT ® Bubblegum Blowout ® Anticavity Kids Fluoride Rinse active ingredient*

BUBBLE GUM FLAVOR

Kids Anticavity Fluoride Rinse

Strong cavity protection

Helps strengthen teeth

ADA Accepted

American Dental Assoication

  • Helps prevent cavities

ALCOHOL FREE

IMPORTANT: Read directions for proper use.

18 FL OZ (1.12 PT) 532 mL

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, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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