Mastic Dent
FDA Label NDC 15304-4085

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chia Gi Ltd for the product Mastic Dent (NDC 15304-4085). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, warnings, keep out of reach., directions, other information, inactive ingredients, information of owner, purpose section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug Facts:

Active Ingredients:

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

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.

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.

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.

Other Information

Other Information:

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

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

Purpose Section

Reduces Gingivitis

Dosage

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

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