drug facts

drug facts
SPL v1
SPL
SPL Set ID 1c7d2a93-6903-4320-bc65-97c510688600
Route
oral
Published
Effective Date 2013-04-22
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 zinc chloride sodium benzoate sucralose saccharin sodium fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-04-22

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 teaspoons ful) mornings 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 (21.6%), Sorbitol Solution, Flavor, Poloxamer 407, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Sodium Saccharin, Blue 1 (CI 42090)

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 accidently swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)


Structured Label Content

Warnings (WARNINGS)

Do not use for children under 12 years of age.

Uses (USES)

To help reduce and prevent plaque and gingivitis

Purpose (PURPOSE)

Antiplaque/Antigingivitis

Directions

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce) or 4 teaspoons ful) mornings 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 (21.6%), Sorbitol Solution, Flavor, Poloxamer 407, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Sodium Saccharin, Blue 1 (CI 42090)

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 accidently swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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