arpha Stain Clear

Manufacturer
Leading Digital Solutions Co Ltd. | YOSUN TECH. CO., LTD.
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:16

Label at a glance#

Productarpha Stain Clear
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

For best results: Use with arpha GF-7/GF-7R blue lightwave vibration toothbrush. Adults and children six years and older: brush teeth thoroughly, preferably after each meal or at least 2 minutes twice a day, or as advised by a dentist or physician.

Storage and handling

Children 2 to 6 years: Use a pea sized amount and supervised by an adult while brushing and rinsing to minimize swallowing. Children under 2 years: Please ask a dentist or physician

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.2%

Purpose

OTC - PURPOSE SECTION

Prevent Cavities

Teeth Whitening

Use

INDICATIONS & USAGE SECTION

Helps protect against cavities and whitens teeth

Warnings

WARNINGS SECTION

Keep out of reach of children under six years of age. DO NOT SWALLOW. Get medical help or contact a Poison Control Center if more than used for brushing is accidently swallowed.

Do not use

OTC - DO NOT USE SECTION

Children under 2 years: Please ask a dentist or physician.

OTC - STOP USE SECTION

Stop use and ask a dentist if: bleeding or redness persists for more than two weeks, painful or swollen gum, pus from the gum line , loose teeth, increase spacing between teeth. These might be signs of severe gum problem.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age. DO NOT SWALLOW. Get medical help or contact a Poison Control Center if more than used for brushing is accidently swallowed.

Directions

DOSAGE & ADMINISTRATION SECTION

For best results:

Use with arpha GF-7/GF-7R blue lightwave vibration toothbrush.

Adults and children six years and older: brush teeth thoroughly, preferably after each meal or at least 2 minutes twice a day, or as advised by a dentist or physician.

Other information

STORAGE AND HANDLING SECTION

Children 2 to 6 years:

Use a pea sized amount and supervised by an adult while brushing and rinsing to minimize swallowing.

Children under 2 years: Please ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydrogen Peroxide, Glycerin, Calcium Phosphate, Water, Calcium Carbonate, Silicon Dioxide, Sodium Coco-Sulfate, Cellulose Gum, Menthol, Teethmate, Sodium Benzoate, Mint Fragrances, Sodium Saccharine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeCarton LabelCarton Label50 g NDC: 80058-002-01

Products#

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DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80058-00280058-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
c70a8d0c-b0b4-06f0-e053-2995a90af967ad312f3d-3b55-10c0-e053-2995a90abce12021-07-13WarningsExact identifier
spl set id: ad312f3d-3b55-10c0-e053-2995a90abce1

Reported adverse events (FAERS/openFDA)#

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