Ora 2 stain clear

Manufacturer
Sunstar Guangzhou Ltd.
Effective date
2020-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:45:47

Label at a glance#

ProductOra 2 stain clear
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day,or use as directed by a dentise or physician children under 6 years Instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years Ask a dentist or physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.1%

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

Warning

WARNINGS SECTION

If more than used for brushing is accidentally swallowed,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and older

Brush teeth thoroughly after meals or at least twice a day,or use as directed by a dentise or physician

children under 6 years

Instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years

Ask a dentist or physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Silica, Sorbital, Glycerin, PEG-8, Sodium Lauryl Sulfate, Disodium C12-14 Pareth-2 Sulfosuccinate,Flavor, Xanthan Gum,,PEG-60 Hydrogenated Castor Oil, Titanium Dioxide, Cellulose Gum, Sodium Fluoride,Sodium Saccharin, Algin, Stevia Rebaudiana Extract, O-Cymen-5-Ol

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

Products#

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DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53050-01153050-011-01, 53050-011-02, 53050-011-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
a031c9bf-10d4-23e4-e053-2995a90a061f68e9f68c-5347-389e-e053-2a91aa0ae7732020-03-06WarningsExact identifier
spl set id: 68e9f68c-5347-389e-e053-2a91aa0ae773

Reported adverse events (FAERS/openFDA)#

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