Mastic Dent Whitening
FDA Label NDC 15304-4182

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 Whitening (NDC 15304-4182). 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, dosage, keep out of reach., directions, 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 0.22% (0.12% w/v fluoride ion) - Anticavity

Warnings

Warnings:

  • When using this product, if irritation occurs discontinue use.
  • Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a poison control Center right away.

Dosage

Use a pea-sized amount

Keep Out Of Reach.

Keep out of reach of children under 6 years of age.

Directions

Directions:

  • Adults and children 2 years and older.
  • Brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Instruct in good brushing and rinsing habits (to minimize swallowing).
  • ​Children under 2 years​ do not use unless directed by a dentist or a physician.

Inactive Ingredients

Inactive Ingredients:

Water, Sorbitol, Hydrated Silica, Glycerine, Sodium Lauroyl Sarcosinate, Peg-8, Calcium Pyrophosphate, Fragrance, Xanthan Gum, Titanium Dioxide, Chamomilla Recutita, Camelia Sinensis, Menthol Crystals, Sodium Saccharin, Allantoin, Pistacia Lentiscus (Mastic) Gum, Bisabolol, Glycyrrhetinic Acid, Sodium Hydroxide

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

Aids in the prevention of dental cavities-plaque

Image Of Label

Toothpaste Box (Toothpastewhitening)

Toothpaste Box (Toothpastewhitening)

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