Label: PLUS153 TOOTHPAST E- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 71553-010-01, 71553-010-02 - Packager: SGS Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 7, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Silica, Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, PEG-1500, D-Sorbitol, Glycerin, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Xylitol, Sodium Saccharin, Sophora Angustifolia Root Extract, Glycyrrhiza Glabra Root Extract, Sodium Benzoate, L-Menthol, Carvone, Anethole, Peppermint Oil, Silver, Water
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Directions
Directions:
Supervise children as necessary until capable of using without supervision.
- Adults and children 6 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 a physician
- children under 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
- children under 6 years: do not use unless directed by a dentist or a physician
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLUS153 TOOTHPAST E
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71553-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.29 g in 40 g Inactive Ingredients Ingredient Name Strength Aminocaproic Acid (UNII: U6F3787206) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71553-010-02 1 in 1 POUCH 06/01/2017 1 NDC:71553-010-01 40 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 OTC monograph final part355 06/01/2017 Labeler - SGS Inc. (688296292) Registrant - SGS Inc. (688296292) Establishment Name Address ID/FEI Business Operations SGS Inc. 688296292 manufacture(71553-010)
