Label: TRADITION SALT CARETOOTHPASTE- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 73065-0007-1 - Packager: WOORILIFE&HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Storage method
1. Keep it at room temperature in a classified container.
2. Cover and store at room temperature.
3. Store in a not moisture and cool place.
4. Air may come out during use of this product, but there is no problem with its weight.
Usage Precautions
1. Be careful not to swallow. Rinse mouth thoroughly after use
2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.
3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.
4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.
5. Keep out of the reach of children under 6 years of age.
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INACTIVE INGREDIENT
Dental type Silica
Ursodeoxycholic Acid
Potassium Phosphate, Dibasic
Potassium Phosphate, Monobasic
Tocopherol Acetate
Glycerine
Grapefruit Seed Extract
Xylitol
Carboxymethylcellulose Sodium
Xanthan gum
Stevioside
Peppermint oil
sodium chloride
Citric acid
Green tea Extract
D-Sorbitol
dl-menthol
Cocamidopropyl Betaine
Purified Water - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRADITION SALT CARETOOTHPASTE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73065-0007 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73065-0007-1 120 g in 1 TUBE; Type 0: Not a Combination Product 04/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/11/2021 Labeler - WOORILIFE&HEALTH (694860803) Registrant - WOORILIFE&HEALTH (694860803) Establishment Name Address ID/FEI Business Operations WOORILIFE&HEALTH 694860803 manufacture(73065-0007) , label(73065-0007)
