PORORO TOOTHPAS TE APPLE- sodium monofluorophosphate paste, dentifrice

Pororo Toothpas te Apple by

Drug Labeling and Warnings

Pororo Toothpas te Apple by is a Otc medication manufactured, distributed, or labeled by KMPHARMACEUTICAL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.35%

INACTIVE INGREDIENT

Inactive Ingredients: Sorbitol, Water, Hydrated Silica, Silica, Sodium Lauryl Sulfate, Apple Flavor, PEG-32, Carboxymethylcellulose Sodium, Sodium Saccharin, Xylitol

PURPOSE

Purpose: Oral Health Care

WARNINGS

Warnings: Keep out of reach of children under 6 years of age. If more accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Indications & usage: Helps protect against cavities

Directions

Directions: 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 doctor. Children under 6 years of age: Ask a dentist or physician. Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PORORO TOOTHPAS TE APPLE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50555-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.31 g  in 90 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50555-020-02	1 in 1 CARTON	08/01/2016
1	NDC: 50555-020-01	90 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	08/01/2016

Labeler - KMPHARMACEUTICAL CO.,LTD (688679158)

Registrant - KMPHARMACEUTICAL CO.,LTD (688679158)

Establishment
Name	Address	ID/FEI	Business Operations
KMPHARMACEUTICAL CO.,LTD		688679158	manufacture(50555-020)