arpha Stain Clear by YOSUN TECH. CO., LTD. Yosun Toothpaste

arpha Stain Clear by

Drug Labeling and Warnings

arpha Stain Clear by is a Otc medication manufactured, distributed, or labeled by YOSUN TECH. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARPHA STAIN CLEAR- sodium fluoride paste 
YOSUN TECH. 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.

----------

Yosun Toothpaste

Active Ingredient(s)

Sodium Fluoride 0.2%

Hydrogen peroxide 0.5 %

Warnings

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

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

Directions

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

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

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

Prevent Cavities

Teeth Whitening

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.

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.

Helps protect against cavities and whitens teeth

Package Label - Principal Display Panel

50 g NDC: 75604-002-01

ARPHA STAIN CLEAR 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75604-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MENTHOL (UNII: L7T10EIP3A)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
MINT (UNII: FV98Z8GITP)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75604-002-01	1 in 1 CARTON	08/12/2020
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/12/2020	08/12/2020

Labeler - YOSUN TECH. CO., LTD. (656018189)

Establishment
Name	Address	ID/FEI	Business Operations
YOSUN TECH. CO., LTD.		656018189	manufacture(75604-002)

Revised: 5/2021

Document Id: c19c3282-e4e9-5d9c-e053-2995a90af512

34390-5

Set id: acba44ac-2248-dece-e053-2a95a90af207

Version: 3

Effective Time: 20210505