Quality Choice 664.003/664at Rev 2 - 664au

Quality Choice 664.003/664at Rev 2 - 664au
SPL v3
SPL
SPL Set ID bd8a4b8b-cd59-4d0d-8ceb-40bba777e61b
Route
ORAL
Published
Effective Date 2025-03-25
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 Water Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-02

Description

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

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

QC 100% SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. Novi, MI 48376 www.qualitychoice.com Questions: 800-935-2362 DSP-TN-21091 DSP-MO-20087


Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48376

www.qualitychoice.com

Questions: 800-935-2362

DSP-TN-21091

DSP-MO-20087

Description

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

Use

helps control plaque that leads to gingivitis

Stop Use

and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

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 twice a day for 30 seconds then spit out; do not swallow

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

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Cool Mint ®Listerine ® Antiseptic Mouthwash.

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.

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. 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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Principal Display Panel

Sealed With Printed Neckband For Your Protection

NDC 83324-179-33

QC ®

Quality

Choice

Compare to Cool Mint ® LISTERINE ®*

Antiseptic

Mouth Rinse

Antigingvitis/Antiplaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingiviis

Gum Disease

BLUE MINT

1 L (1.05 QT) 33.8 FL OZ

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

Stop Use (Stop use)

and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

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 twice a day for 30 seconds then spit out; do not swallow

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

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Cool Mint ®Listerine ® Antiseptic Mouthwash.

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 Reactions

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48376

www.qualitychoice.com

Questions: 800-935-2362

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°-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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Principal Display Panel (principal display panel)

Sealed With Printed Neckband For Your Protection

NDC 83324-179-33

QC ®

Quality

Choice

Compare to Cool Mint ® LISTERINE ®*

Antiseptic

Mouth Rinse

Antigingvitis/Antiplaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingiviis

Gum Disease

BLUE MINT

1 L (1.05 QT) 33.8 FL OZ

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

All Sections (JSON)