Rexall 664.003/664at Rev2 - 664au

Rexall 664.003/664at Rev2 - 664au
SPL v22
SPL
SPL Set ID 1cfd85f3-ef19-46f6-8225-287a8a0a32fd
Route
ORAL
Published
Effective Date 2025-05-06
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 Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1994-07-29 Until 2019-12-01

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Antigingivitis, antiplaque


Medication Information

Purpose

Antigingivitis, antiplaque

Description

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 teaspoons) between teeth 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
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

Since 1903 Rexall™ is a registered trademark of Rexall Sundown, Inc.

Distributed by Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

100% Satisfaction Guaranteed!

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888) 309-9030

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°-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

Since 1903

Rexall™

Blue Mint

Antiseptic Mouthwash

Antigingivitis/Antiplaque

  • Kills 99.9% of germs commonly associated with gingivitis
  • Fights bad breath
  • Helps reduce plaque

ADA Accepted

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 teaspoons) between teeth 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
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

Since 1903 Rexall™ is a registered trademark of Rexall Sundown, Inc.

Distributed by Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

100% Satisfaction Guaranteed!

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888) 309-9030

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)

Since 1903

Rexall™

Blue Mint

Antiseptic Mouthwash

Antigingivitis/Antiplaque

  • Kills 99.9% of germs commonly associated with gingivitis
  • Fights bad breath
  • Helps reduce plaque

ADA Accepted

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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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