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

Adverse Reactions

Purpose

Anticavity

Description

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

Medication Information

Warnings

For this product

Purpose

Anticavity

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

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-8484

Quality Guaranteed or your money back.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

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

Description

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

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

Use

aids in the prevention of dental cavities

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)

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

Warnings

For this product

Purpose

Anticavity

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

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-8484

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

Use

aids in the prevention of dental cavities

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)

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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": "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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