Care One 855.000/855aa-ac

Care One 855.000/855aa-ac
SPL v5
SPL
SPL Set ID 93e84b24-240e-4f86-98a3-0fed7584c186
Route
ORAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Zinc Chloride Sodium Benzoate Sucralose Saccharin Sodium Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-13

Description

Sealed With Printed Neckband For Your Protection

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Sealed With Printed Neckband For Your Protection

Tep

Sealed With Printed Neckband For Your Protection

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing
Do Not Use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction

*This product is not manufactured or distributed by Johnson & Johnson Corportation, distributor of Listerine Ultraclean Coll Mint Antiseptic Mouthwash

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contract us at 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

 water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

Principal Display Panel

CAREONE

Compare to Listerine UltracleanCool Mint*

ANTISEPTIC

MOUTH RINSE PLUS

ANTIGINGIVITIS/ANTIPLAQUE

CONTROLS TARTAR

FIGHTS PLAQUE AND GINGIVITIS

FRESH BREATH WITH LONG LASTING CLEAN FEEL

BLUE MINT FLAVOR

NET 33.8 FL OZ (1.05 QT) 1 L

Stop Use and Ask A Dentist If

gingivitis, bleeding, or redness persists for more than 2 weeks.

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

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing
Do Not Use (Do not use)

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction (ADVERSE REACTION)

*This product is not manufactured or distributed by Johnson & Johnson Corportation, distributor of Listerine Ultraclean Coll Mint Antiseptic Mouthwash

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contract us at 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

Other Information (Other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

 water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

Principal Display Panel (Principal display panel)

CAREONE

Compare to Listerine UltracleanCool Mint*

ANTISEPTIC

MOUTH RINSE PLUS

ANTIGINGIVITIS/ANTIPLAQUE

CONTROLS TARTAR

FIGHTS PLAQUE AND GINGIVITIS

FRESH BREATH WITH LONG LASTING CLEAN FEEL

BLUE MINT FLAVOR

NET 33.8 FL OZ (1.05 QT) 1 L

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or redness persists for more than 2 weeks.

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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