OTC Medication Information: DOCTRUST DOUBLEX Tooth

DOCTRUST DOUBLEX TOOTH- sodium fluoride paste, dentifrice
Dr.s Medi Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Sodium fluoride 0.22%
(Total Fluoride Content 1,000 ppm Approx.)

INACTIVE INGREDIENTS

Sodium Tocopheryl Acetate, Silicon Dioxide, Chitosan, Propolis Extract, D-sorbitol Solution, Sodium Carboxymethyl Cellulose, Licorice Extract, Ascorbic Acid, Camellia Sinensis Extract, Curcumin Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoylglutamate, Sodium Bicarbonate, L-menthol, Peppermint Oil, Purified Water

PURPOSE

Anticavity Toothpaste

WARNINGS

■ Do not swallow and rinse mouth thoroughly after use
■ 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

■ Helps protect against cavities

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.
■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
■ Children under 2 years: 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

Image of carton
(click image for full-size original)

DOCTRUST DOUBLEX TOOTH
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76670-0010
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium fluoride (FLUORIDE ION) FLUORIDE ION 0.22 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
PROPOLIS WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76670-0010-2 1 TUBE in 1 CARTON contains a TUBE (76670-0010-1)
1 NDC:76670-0010-1 100 g in 1 TUBE This package is contained within the CARTON (76670-0010-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/01/2021
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 (76670-0010)

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.

Terms of Use | Copyright © 2022. All Rights Reserved.