drug facts

drug facts
SPL v1
SPL
SPL Set ID 93d90796-b74b-4948-858a-1a501676bc10
Route
oral
Published
Effective Date 2017-03-31
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 not final active Since 2017-03-29

Purpose

Antiplaque/Antigingivitis

Description

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


Medication Information

Warnings

Do not use for children under 12 years of age.

Uses

to help reduce and prevent plaque and gingivitis.

Purpose

Antiplaque/Antigingivitis

Directions
  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • Do not swallow
Other Information
  • Store at room temperature.
  • Cold weather may cloud this product. Its antiseptic properties are not affected.
Inactive Ingredients

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Description

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

Label Copy

Active Ingredients

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

Questions Or Comments?

1-800-842-7886

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Warnings

Do not use for children under 12 years of age.

Uses

to help reduce and prevent plaque and gingivitis.

Purpose

Antiplaque/Antigingivitis

Directions
  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • Do not swallow
Other Information (Other information)
  • Store at room temperature.
  • Cold weather may cloud this product. Its antiseptic properties are not affected.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Label Copy

Active Ingredients (Active ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-842-7886

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 (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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