PORORO TOOTHPAS TE PINEAPPLE- sodium monofluorophosphate paste, dentifrice
KMPHARMACEUTICAL 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.

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ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.35%

INACTIVE INGREDIENT

Inactive Ingredients: Sorbitol, Water, Hydrated Silica, Silica, Sodium Lauryl Sulfate, Pineapple 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

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PORORO TOOTHPAS TE PINEAPPLE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50555-030
Route of Administration	ORAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50555-030-02	1 in 1 CARTON	08/01/2016	01/15/2021
1	NDC:50555-030-01	90 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/01/2016	01/15/2021

Labeler - KMPHARMACEUTICAL Co.,Ltd. (688679158)

Registrant - KMPHARMACEUTICAL Co.,Ltd. (688679158)

Name	Address	ID/FEI	Business Operations
Establishment
KMPHARMACEUTICAL Co.,Ltd.		688679158	manufacture(50555-030)

Revised: 6/2021

Document Id: 9aba6f26-1737-45f0-9b3d-7bfdcb140410

Set id: 59177442-d403-497c-99fb-5409af11cbca

Version: 2

Effective Time: 20210601

KMPHARMACEUTICAL Co.,Ltd.