SPL v2
SPL
SPL Set ID 9512b4f1-d933-43d7-b31e-2245e2aa3eee
Routes
ORAL DENTAL
Published
Effective Date 2012-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.25 mg) Eucalyptol (0.92 mg) Thymol (0.64 mg) Menthol (0.42 mg)
Inactive Ingredients
Sorbitol Pistacia Lentiscus Seed Oil Pistacia Lentiscus Resin Sodium Benzoate Alcohol Saccharin Sodium Sodium Lauroyl Sarcosinate Edetate Disodium Sodium Phosphate Polyoxyl 40 Hydrogenated Castor Oil Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2005-11-22

Description

Drug Facts: Active Ingredients: Sodium Fluoride 0.025% - Anticavity Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque Thymol 0.064% - Antigingivitis, Antiplaque

Purpose

Reduces Gingivitis


Medication Information

Purpose

Reduces Gingivitis

Description

Drug Facts: Active Ingredients: Sodium Fluoride 0.025% - Anticavity Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque Thymol 0.064% - Antigingivitis, Antiplaque

Dosage

Dosage - Vigorously swish 20mL (2/3 Fl. OZ or 4 team - spoonfuls) between teeth for 30 seconds, then spit out do not swallow.

Warnings

Warning:

  • Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.
  • Stop use and ask dentist if gingivitis, bleeding, or redness persists more than 2 weeks.


Directions

Directions:

  • Adults and children 12 of age and older - Vigorously swish 20mL (2.3 Fl. Oz or 4 tea-spoonfuls) between teeth for 30 seconds then spit out, do not swallow.
  • Children under 12 years of age - Consult a dentist or doctor
  • This rinse is not intended to replace brushing or flossing.
Purpose Section

Reduces Gingivitis

Other Information

Other Information:

  • Cold weather may cloud this product. Its anticeptic properties are not affected. Store at room temperature (25 C - 77 F).
Active Ingredients

Drug Facts:

Active Ingredients:

  • Sodium Fluoride 0.025% - Anticavity
  • Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque
  • Thymol 0.064% - Antigingivitis, Antiplaque


Keep Out of Reach.

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Imageofmouthwash.jpg

Inactive Ingredients

Inactive Ingredients:

AQUA, Alcohol Denaturated, Sorbitol, Sodium Lauroyl Sarcosinate, Sodium Phosphate, Peg-40 Hydrogenated Castor Oil, Sodium Benzoate, Fragrance, Disodium EDTA, Sodium Saccharin, Pistacia Lentiscus Mastic Gum, Pistacia Lentiscus Seed Oil, Acid Blue 9 CI 42090

Information of Owner

Product Of Chios

CHIA GI LTD

144 AG. MINA, HIOS, 82100

GREECE

Tel.: 30-22710-33101, FAX: 30-22710-32229

www.masticspa.com

Made In Greece


Structured Label Content

Dosage

Dosage - Vigorously swish 20mL (2/3 Fl. OZ or 4 team - spoonfuls) between teeth for 30 seconds, then spit out do not swallow.

Warnings

Warning:

  • Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.
  • Stop use and ask dentist if gingivitis, bleeding, or redness persists more than 2 weeks.


Directions

Directions:

  • Adults and children 12 of age and older - Vigorously swish 20mL (2.3 Fl. Oz or 4 tea-spoonfuls) between teeth for 30 seconds then spit out, do not swallow.
  • Children under 12 years of age - Consult a dentist or doctor
  • This rinse is not intended to replace brushing or flossing.
Purpose Section (PURPOSE SECTION)

Reduces Gingivitis

Other Information (Other information)

Other Information:

  • Cold weather may cloud this product. Its anticeptic properties are not affected. Store at room temperature (25 C - 77 F).
Active Ingredients

Drug Facts:

Active Ingredients:

  • Sodium Fluoride 0.025% - Anticavity
  • Eucalyptol 0.092%, Menthol 0.042% - Antigingivitis , Antiplaque
  • Thymol 0.064% - Antigingivitis, Antiplaque


Keep Out of Reach. (Keep out of reach.)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Imageofmouthwash.jpg (ImageofMouthwash.jpg)

Inactive Ingredients

Inactive Ingredients:

AQUA, Alcohol Denaturated, Sorbitol, Sodium Lauroyl Sarcosinate, Sodium Phosphate, Peg-40 Hydrogenated Castor Oil, Sodium Benzoate, Fragrance, Disodium EDTA, Sodium Saccharin, Pistacia Lentiscus Mastic Gum, Pistacia Lentiscus Seed Oil, Acid Blue 9 CI 42090

Information of Owner (Information of owner)

Product Of Chios

CHIA GI LTD

144 AG. MINA, HIOS, 82100

GREECE

Tel.: 30-22710-33101, FAX: 30-22710-32229

www.masticspa.com

Made In Greece


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)