Care One 971.001/971ab

Care One 971.001/971ab
SPL v5
SPL
SPL Set ID 3954edfd-f7f1-4218-9ee2-23f5b3661b4e
Route
ORAL
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-08

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

Purpose 

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL 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 Consumer Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Warnings 

For this product

Adverse Reaction

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions and 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)

Other Information
  • store at controlled room temperature 20°-25°C (68°–77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display

CAREONE ®

Compare to Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*

BURN FREE FLUORIDE

ANTI-CAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

HELPS STRENGTHEN TEETH TO FIGHT CAVITIES

HELPS RESTORE ENAMEL

FRESH MINT FLAVOR

IMPORTANT: read directions for proper use.

NET 33.8 FL OZ (1.05 QT) 1 L

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, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose 

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL 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 Consumer Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Warnings 

For this product

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions and 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)

Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68°–77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display

CAREONE ®

Compare to Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*

BURN FREE FLUORIDE

ANTI-CAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

HELPS STRENGTHEN TEETH TO FIGHT CAVITIES

HELPS RESTORE ENAMEL

FRESH MINT FLAVOR

IMPORTANT: read directions for proper use.

NET 33.8 FL OZ (1.05 QT) 1 L

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, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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