OTC Medication Information: DOCTRUST ONE S Tooth

DOCTRUST ONE S TOOTH- sodium fluoride, silicon dioxide and potassium nitrate paste, dentifrice
Dr.s Medi Co.,Ltd.

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 INGREDIENT

Sodium fluoride 0.0221%
(Total Fluoride Content 1,000 ppm Approx.)
Dental type silica 17.50%
Potassium nirate 5.00%

INACTIVE INGREDIENTS

Sodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

PURPOSE

Anti plaque, Anticaries, Anticavity, Antihypersensitivity

WARNINGS

■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if
■ For children under 6 years of age, use small amounts of toothpaste.
under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

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

Uses

■ Builds increasing protection against painful sensitivity
■ Aids in the prevention of dental cavities.

Directions

■ Adults and children 12 years of age and older:
• Apply at least 1-inch strip of the product onto a soft bristle toothbrush
• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
■ Children under 12 years of age: Consult a dentist or doctor.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

https://docsmedi.kr
Tel: 82-031-922-2240, Fax: 82-43-883-2844

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DOCTRUST ONE S TOOTH
sodium fluoride, dental type silica, potassium nirate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76670-0011
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium fluoride (FLUORIDE ION) FLUORIDE ION 0.02 g in 100 g
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 17.50 g in 100 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 5.00 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SORBITOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76670-0011-2 1 TUBE in 1 CARTON contains a TUBE (76670-0011-1)
1 NDC:76670-0011-1 100 g in 1 TUBE This package is contained within the CARTON (76670-0011-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2021
Labeler — Dr.s Medi Co.,Ltd. (694505169)
Registrant — Dr.s Medi Co.,Ltd. (694505169)
Establishment
Name Address ID/FEI Operations
DONG IL PHARMS CO., LTD. 557810721 manufacture (76670-0011)

Revised: 09/2022 Dr.s Medi Co.,Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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