Leading Digital Toothpaste 002-01

arpha Stain Clear by

Drug Labeling and Warnings

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

Drug Details [pdf]

ARPHA STAIN CLEAR- sodium flouride paste 
Leading Digital Solutions 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.

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Leading Digital Toothpaste 002-01

Active Ingredient(s)

Sodium Fluoride 0.2%

Purpose

Prevent Cavities

Teeth Whitening

Use

Helps protect against cavities and whitens teeth

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.

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.

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

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

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

TubeCarton Label50 g NDC: 80058-002-01

ARPHA STAIN CLEAR 
sodium flouride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80058-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MENTHOL (UNII: L7T10EIP3A)  
MINT (UNII: FV98Z8GITP)  
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80058-002-011 in 1 CARTON08/19/2020
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/19/202007/13/2021
Labeler - Leading Digital Solutions Co Ltd. (117585456)

Revised: 7/2021