Label: PHYENLIMCIDE TOOTHPASTE- silicon dioxide paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 82336-010-01, 82336-010-02 - Packager: WOORIZ Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated October 22, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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
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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
- Questions
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INACTIVE INGREDIENTS
D-sorbitol Solution,L-Menthol,Sophora Extract,Glycerin,Aminocaproic Acid,Geen Tea Extract,Aluminum Chlorohydroxy Allantoinate,Lemon Extract,Mastic Oil,Myrrh Tincture,Sodium Saccharin,Aloe Extract(09),Eucalyptus Globulus Leaf Oil,Xylitol,Water,Sodium Chloride,Carboxymethylcellulose Sodium,Camomille Extract(1),Sodium Cocoyl Glutamate,Peppermint Oil,Chamaecyparis Obtusa Oil,Propolis Extract,Hydroxyapatite,Scutellaria Root Extract
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHYENLIMCIDE TOOTHPASTE
silicon dioxide paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82336-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon Dioxide 24.0 g in 160 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) LEVOMENTHOL (UNII: BZ1R15MTK7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82336-010-02 1 in 1 CARTON 10/01/2021 1 NDC:82336-010-01 160 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2021 Labeler - WOORIZ Co.,Ltd. (695143249) Registrant - WOORIZ Co.,Ltd. (695143249) Establishment Name Address ID/FEI Business Operations Korea Life Science Co.,ltd 694914835 manufacture(82336-010)
