Rexall 318.003/318ah-ai

Rexall 318.003/318ah-ai
SPL v26
SPL
SPL Set ID 76554d61-ed96-4631-9140-135f1a2e282b
Route
ORAL
Published
Effective Date 2025-04-02
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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-01-11 Until 2022-08-03

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 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 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

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

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

Distributed by Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

DSP-TN-21091

DSP-MO-20087

Active Ingredient

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Other Information

 cold weather may cloud this product. Its antiseptic properties are not affected.  Store at room temperature (59⁰-77⁰F).

Inactive Ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel

Since 1903

Rexall™

Amber

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

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

ADA Accepted

Amrican 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 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 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 (ADVERSE REACTION)

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

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

Distributed by Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Other Information (Other information)

 cold weather may cloud this product. Its antiseptic properties are not affected.  Store at room temperature (59⁰-77⁰F).

Inactive Ingredients (Inactive ingredients)

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel (Principal display panel)

Since 1903

Rexall™

Amber

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

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

ADA Accepted

Amrican 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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