Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9f94b147-7b4b-4fdd-a040-e66ab3609048
Route
ORAL
Published
Effective Date 2018-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.60 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Poloxamer 407 Benzoic Acid Saccharin Sodium Sucralose Sodium Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-28

Description

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis


Medication Information

Purpose

Antiplaque/Antigingivitis

Description

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Warnings

Stop use and ask a doctor if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodonitis, a serious form of gum disease.
Directions
  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Label Copy

Other Information
  • this rinse is not intended to replace brushing or flossing
  • store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients

Water (Aqua), Alcohol (21.6%), Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sucralose, Sodium Benzoate, Green 3 (CI 42053).

Questions Or Comments?

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Purpose

Antiplaque/Antigingivitis

Warnings

Stop use and ask a doctor if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodonitis, a serious form of gum disease.
Directions
  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Label Copy

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
  • store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients (Active ingredients)

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Alcohol (21.6%), Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sucralose, Sodium Benzoate, Green 3 (CI 42053).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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