TRADER JOES- sodium fluoride 0.24% and potassium nitrate 5% paste

Trader Joes by

Drug Labeling and Warnings

Trader Joes by is a Otc medication manufactured, distributed, or labeled by TRADER JOE'S COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

• Potassium Nitrate .......... 5%
• Sodium Fluoride ............ 0.24%

Purposes

• Anti-hypersensitivity
• Anticavity

Uses

• builds increasing protection against painful sensitivity of the teeth to

cold, heat, acids, sweets, or contact.

• aids in the prevention of dental cavities.

Warnings

Stop use and contact a dentist if

• the problem persists or worsens. Sensitive teeth may indicate a serious

problem that may need prompt care by a dentist.

• pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control
Center right away.

Directions

• Adults and children 12 years of age and older:
  • apply at least a 1-inch strip of the product onto a soft bristle

toothbrush.

• brush teeth thoroughly for at least 1 minute twice a day (morning

and evening), and not more than 3 times a day, or as recommended
by a dentist or doctor. Make sure to brush all sensitive areas of the
teeth. Minimize swallowing. Spit out after brushing.

• Children under 12 years of age: Consult a dentist or doctor.

Other information

• do not use above 25°C (77°F)
• do not use if seal under cap is broken or missing.

Inactive ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Xylitol, Xanthan Gum, Natural Flavor, Cocamidopropyl Betaine, Sodium
Cocoyl Glutamate, Stevia Rebaudiana Extract, Mentha Piperita (Peppermint) Oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRADER JOES 
sodium fluoride 0.24% and potassium nitrate 5% paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71270-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
PEPPERMINT OIL (UNII: AV092KU4JH)
XANTHAN GUM (UNII: TTV12P4NEE)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71270-110-06	170 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/01/2024

Labeler - TRADER JOE'S COMPANY (006226666)