D.S Crystal Tooth: Package Insert and Label Information

D.S CRYSTAL TOOTH- calcium carbonate and sodium chloride paste, dentifrice
Taeyang Crystal

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENTS

Calcium Carbonate 24.0%
Sodium Chloride 3.0%

INACTIVE INGREDIENTS

Sorbitol, Water, Glycerin, Erythritol, Silica, PEG-32, Sodium Lauryl Sulfate, Cellulose Gum, Sorbitan oleate, Menthol, Methylparaben, Mentha Piperita (Peppermint) Oil, Fragrance

PURPOSE

Anti cavity

WARNINGS

Adults and children 2 years of age and older: apply a 1-inch strip of product onto a toothbrush. Brush teeth thoroughly for 3 minutes three times a day (morning, afternoon, evening) or as recommended by a dentist. Do not swallow.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps fight and protect against cavities for healthier teeth.
■ Refresh your day with a strong mint flavor, which leaves your mouth feeling fresh and clean.

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or three times a day, or as directed by a dentist or physician
■ Children 2 to 6 years: Use only a pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing)
■ Children under 2 years: Consult a dentist

QUESTIONS

■ +82-31-837-8857

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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D.S CRYSTAL TOOTH
calcium carbonate, sodium chloride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81569-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Carbonate (CALCIUM CATION) CALCIUM CATION 28.8 g in 120 g
Sodium Chloride (CHLORIDE ION) Sodium Chloride 3.6 g in 120 g
Inactive Ingredients
Ingredient Name Strength
Sorbitol
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81569-010-02 1 TUBE in 1 CARTON contains a TUBE (81569-010-01)
1 NDC:81569-010-01 120 g in 1 TUBE This package is contained within the CARTON (81569-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2021
Labeler — Taeyang Crystal (688959504)
Registrant — Taeyang Crystal (688959504)
Establishment
Name Address ID/FEI Operations
EQMAXON Corp. 557821534 manufacture (81569-010)

Revised: 02/2021 Taeyang Crystal

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