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

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium chloride 0.05%


Medication Information

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.

Purpose

Antigingivitis, Antiplaque

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
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

Description

Cetylpyridinium chloride 0.05%

Principal Display Panel

Use

helps control plaque that leads to gingivitis

Active Ingredient

Cetylpyridinium chloride 0.05%

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

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.

Purpose

Antigingivitis, Antiplaque

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
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)

Use

helps control plaque that leads to gingivitis

Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.05%

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

All Sections (JSON)