Care One 482.002/482ac

Care One 482.002/482ac
SPL v20
SPL
SPL Set ID 542e067a-c134-44c9-b962-f2a2b667b76f
Route
ORAL
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Glycerin Cetylpyridinium Chloride Cinnamaldehyde Saccharin Sodium Phosphoric Acid Sodium Benzoate Sucralose Poloxamer 407 Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Propylene Glycol D&c Red No. 33 Water Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-02-01

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Tep

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 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 rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ® Advanced Anticavity Flouride Mouthwash Enamel Care Alcohol Free.

**This product is not intended to replace brushing or flossing.

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Active Ingredient

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

Inactive Ingredients

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel

CAREONE ®

Compare to the Active Ingredient in Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash*

ALCOHOL FREE

FLUORIDE MOUTHWASH

ANTICAVITY

FLUORIDE RINSE

VIOLET MINT FLAVOR

KILLS BAD BREATH GERMS

HELPS PREVENT CAVITIES

HELPS STRENGTHEN ENAMEL

CLEANS TEETH**

FRESHENS BREATH

IMPORTANT: Read directions for proper use

33.8 FL OZ (1.05 QT) 1L

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

Tep (TEP)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 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 rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ® Advanced Anticavity Flouride Mouthwash Enamel Care Alcohol Free.

**This product is not intended to replace brushing or flossing.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel (Principal display panel)

CAREONE ®

Compare to the Active Ingredient in Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash*

ALCOHOL FREE

FLUORIDE MOUTHWASH

ANTICAVITY

FLUORIDE RINSE

VIOLET MINT FLAVOR

KILLS BAD BREATH GERMS

HELPS PREVENT CAVITIES

HELPS STRENGTHEN ENAMEL

CLEANS TEETH**

FRESHENS BREATH

IMPORTANT: Read directions for proper use

33.8 FL OZ (1.05 QT) 1L

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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