Care One 435.000/435aa

Care One 435.000/435aa
SPL v15
SPL
SPL Set ID cf0c8b48-0d1c-406a-a67d-7d16187d38d8
Route
ORAL
Published
Effective Date 2025-04-15
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 2015-06-01
Description

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

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY: FOODHOLD U.S.A., LLC LANDOVER, MD 20785 1-877-846-8484 ©2018 S & S brands, LLC Quality Guaranteed or your money back. DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Medication Information

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-8484

©2018 S & S brands, LLC

Quality Guaranteed or your money back.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Description

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

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.

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

Active Ingredient

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

Other Information

store at room temperature (59º-77ºF)

Inactive Ingredients

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

Principal Display Panel

CAREONE ®

Compare to Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse*

ADVANCED

WHITENING

ANTICAVITY MOUTHRINSE

5 DAYS TO WHITER TEETH

BEGINS WORKING ON CONTACT

SAFELY WHITENS TEETH

KILLS GERMS THAT CAUSE BAD BREATH

FRESH MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use.

32 FL OZ (1 QT) 946 mL

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.

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

Active Ingredient

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

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-8484

©2018 S & S brands, LLC

Quality Guaranteed or your money back.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information (Other information)

store at room temperature (59º-77ºF)

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)

CAREONE ®

Compare to Listerine ®HealthyWhite™ Vibrant Anticavity Mouthrinse*

ADVANCED

WHITENING

ANTICAVITY MOUTHRINSE

5 DAYS TO WHITER TEETH

BEGINS WORKING ON CONTACT

SAFELY WHITENS TEETH

KILLS GERMS THAT CAUSE BAD BREATH

FRESH MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use.

32 FL OZ (1 QT) 946 mL

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:34.590580 · Updated: 2026-03-14T23:12:50.471535