Care One 004.002/004ae

Care One 004.002/004ae
SPL v8
SPL
SPL Set ID 77c066cf-f064-45d3-9732-4433165ba9ef
Route
ORAL
Published
Effective Date 2025-05-21
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 2010-03-10 Until 2023-09-18

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
Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Kids Anticavity Fluoride Rinse Bubblegum Blowout .

Adverse Reaction

Distributed by Foodhold, U.S.A, LLC

Landover, MD 20785 • 1-877-846-9949

©2018 S&S Brands, Inc.

Quality Guaaranteed or your money back.

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

CAREONE ®

Compare to Act ®Kids Anticavity Fluride Rinse*

CHILDREN'S

ANTICAVITY

FLUORIDE RINSE

Strong Cavity

Protection

Alcohol-Free

BUBBLE GUM FLAVOR

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use.

18 FL OZ (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
Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Kids Anticavity Fluoride Rinse Bubblegum Blowout .

Adverse Reaction (ADVERSE REACTION)

Distributed by Foodhold, U.S.A, LLC

Landover, MD 20785 • 1-877-846-9949

©2018 S&S Brands, Inc.

Quality Guaaranteed or your money back.

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)

CAREONE ®

Compare to Act ®Kids Anticavity Fluride Rinse*

CHILDREN'S

ANTICAVITY

FLUORIDE RINSE

Strong Cavity

Protection

Alcohol-Free

BUBBLE GUM FLAVOR

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use.

18 FL OZ (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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