arpha Stain Clear

Manufacturer
YOSUN TECH. CO., LTD.
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:18:13

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%

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.

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

OTC - PURPOSE SECTION

Prevent Cavities

Teeth Whitening

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.

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.

INDICATIONS & USAGE SECTION

Helps protect against cavities and whitens teeth

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube LabelOuter Box LabelOuter Box Label50 g NDC: 75604-002-01

Products#

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DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75604-00275604-002-01

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
c19c3282-e4e9-5d9c-e053-2995a90af512acba44ac-2248-dece-e053-2a95a90af2072021-05-05WarningsExact identifier
spl set id: acba44ac-2248-dece-e053-2a95a90af207

Reported adverse events (FAERS/openFDA)#

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