Care One 163.004/163ae

Care One 163.004/163ae
SPL v13
SPL
SPL Set ID 35385ada-bd8d-4d38-9587-0256885f749f
Route
ORAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-09-12

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

Warnings

for this product

Directions

Adults and children 12 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 of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2018 S&S BRANDS, LLC

Quality guaranteed or your money back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient

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

Other Information
  • store at controlled room temperature 20⁰ -25⁰ (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

CARE ONE ®

Compare to Listerine ®Total Care Fresh Mint Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

Helps prevent cavities and restore enamel

Helps strengthen teeth 

Freshens breath

Mint Flavor

IMPORTANT: Read directions for proper use.

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

Warnings

for this product

Directions

Adults and children 12 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 of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine ®Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2018 S&S BRANDS, LLC

Quality guaranteed or your money back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • store at controlled room temperature 20⁰ -25⁰ (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (Principal display panel)

CARE ONE ®

Compare to Listerine ®Total Care Fresh Mint Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

Helps prevent cavities and restore enamel

Helps strengthen teeth 

Freshens breath

Mint Flavor

IMPORTANT: Read directions for proper use.

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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