Care One 664.003 664at Rev 2 664au

Care One 664.003 664at Rev 2 664au
SPL v4
SPL
SPL Set ID 68d03df5-4966-452e-9c18-e109ee135941
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
Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate Fd&c Green No. 3 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1992-09-15

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Directions
  • do not swallow
  • not intended to replace brushing or flossing

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

children under 12 years of age - consult a dentist or doctor

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 Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-845-9949

(c)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 (59° - 77°F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel

Care One

Compare to Cool Mint Listerine Antiseptic Mouthwash*

Antiseptic Mouth rinse

Antigingivitis/Antiplaque

Kills Germs that Cause bad breath, plaque and the gum disease gingivitis

Blue Mint flavor

Sealed with printed neckband for your protection

8.5 FL OZ (250 mL)

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

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions
  • do not swallow
  • not intended to replace brushing or flossing

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

children under 12 years of age - consult a dentist or doctor

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 Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-845-9949

(c)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 (59° - 77°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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel (Principal display panel)

Care One

Compare to Cool Mint Listerine Antiseptic Mouthwash*

Antiseptic Mouth rinse

Antigingivitis/Antiplaque

Kills Germs that Cause bad breath, plaque and the gum disease gingivitis

Blue Mint flavor

Sealed with printed neckband for your protection

8.5 FL OZ (250 mL)

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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