79814-007_mastikis Fresh Gargle

79814-007_mastikis Fresh Gargle
SPL v1
SPL
SPL Set ID 9bb4f058-52ef-46fc-bd2e-a57b8ac6ace2
Route
ORAL
Published
Effective Date 2020-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.5 mg)
Inactive Ingredients
Water Glycerin Xylitol Stevioside Sodium Citrate, Unspecified Form Ascorbic Acid Levomenthol Green Tea Leaf Sodium Benzoate Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-21

Description

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium chloride 0.05%

Use

helps control plaque that leads to gingivitis

Warnings

Ask a dentist before use 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 increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  •  children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use consult a dentist or doctor
Active Ingredient

Cetylpyridinium chloride 0.05%

Other Information
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

Glycerin, Xylitol, Steviol Glycoside, Trisodium Citrate, Ascorbic Acid, L-Menthol, Green Tea Extract, Mastic Oil, Lemon Mint Flavor, Sodium Benzoate, Hydrogenated Caster Oil, Deionized Water

Principal Display Panel

Stop Use and Ask A Dentist 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 increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age

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

Ask a dentist before use 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 increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  •  children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use consult a dentist or doctor
Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.05%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients (Inactive ingredients)

Glycerin, Xylitol, Steviol Glycoside, Trisodium Citrate, Ascorbic Acid, L-Menthol, Green Tea Extract, Mastic Oil, Lemon Mint Flavor, Sodium Benzoate, Hydrogenated Caster Oil, Deionized Water

Principal Display Panel (principal display panel)

Stop Use and Ask A Dentist If (Stop use and ask a dentist 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 increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.
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 accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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