Quality Choice 072.003/072an

Quality Choice 072.003/072an
SPL v3
SPL
SPL Set ID 27ff8499-63e0-49ad-a4dd-dde6da584f93
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
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 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 48375 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 48375

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

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 manufatured or distriubted by Kenvue, Inc., distributor of FreshBurst ®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 (59⁰ - 77⁰ 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, flavor, sodium citrate, D&C yellow no. 10, FD&C green no.3

Principal Display Panel

Sealed With Printed Neckband For Your Protection

NDC 83324-181-33

QC ®

QUALITY

CHOICE

Compare to FreshBurst ®Listerine ®*

Antiseptic

Mouth Rinse

Antigingivitis/Antilaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis

Gum Disease

Spring Mint ®

1 L (1.05 QT) 33.8 FL OZ

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

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 manufatured or distriubted by Kenvue, Inc., distributor of FreshBurst ®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 48375

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 (59⁰ - 77⁰ 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, flavor, sodium citrate, D&C yellow no. 10, FD&C green no.3

Principal Display Panel (Principal display panel)

Sealed With Printed Neckband For Your Protection

NDC 83324-181-33

QC ®

QUALITY

CHOICE

Compare to FreshBurst ®Listerine ®*

Antiseptic

Mouth Rinse

Antigingivitis/Antilaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis

Gum Disease

Spring Mint ®

1 L (1.05 QT) 33.8 FL OZ

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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