PLUS153 TOOTHPAST E- sodium monofluorophosphate paste, dentifrice

PLUS153 Toothpast e by

Drug Labeling and Warnings

PLUS153 Toothpast e by is a Otc medication manufactured, distributed, or labeled by SGS Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Sodium monofluorophosphate 0.74%

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

Purpose: Anticavity

WARNINGS

Warnings: For external use only If more than used for brushing is accidently swallowed get medical help or contact a poison control center immediately Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Uses: Helps protect against cavities.

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

INGREDIENTS AND APPEARANCE

PLUS153 TOOTHPAST E 
sodium monofluorophosphate paste, dentifrice

Product 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)