Pororo Toothpas te Pineapple

Manufacturer
KMPHARMACEUTICAL CO.,LTD
Effective date
2016-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:46

Label at a glance#

ProductPororo Toothpas te Pineapple
Active ingredientSodium Monofluorophosphate
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate 0.35%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Purpose: Oral Health Care

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & usage: Helps protect against cavities

Directions

DOSAGE & ADMINISTRATION SECTION

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

Image of cartonImage of carton

Products#

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DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50555-03050555-030-01, 50555-030-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium MonofluorophosphateC810JCZ56QACTIM
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9aba6f26-1737-45f0-9b3d-7bfdcb14041059177442-d403-497c-99fb-5409af11cbca2021-06-01WarningsExact identifier
spl set id: 59177442-d403-497c-99fb-5409af11cbca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.