LUCKY SUPER SOFT SENSITIVE- sodium fluoride potassium nitrate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Delta Brands Inc

INN (International Name):

POTASSIUM NITRATE

Composition:

POTASSIUM NITRATE 50 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihypersensitivity Anticavity ■ builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact ■ aids in the prevention of dental cavities

Authorization status:

OTC monograph not final

Summary of Product characteristics

LUCKY SUPER SOFT SENSITIVE- SODIUM FLUORIDE POTASSIUM NITRATE PASTE,
DENTIFRICE
DELTA BRANDS INC
_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._
----------
DRUG FACTS
_ACTIVE INGREDIENT_
Potassium nitrate - 5%
Sodium fluoride - 0.24%
_PURPOSE_
Antihypersensitivity
Anticavity
_USES_
■ builds increasing protection against painful sensitivity of teeth
due to cold, heat, acids, sweets or
contact ■ aids in the prevention of dental cavities
_WARNINGS_
WHEN USING THIS PRODUCT ■ if pain/sensitivity still persists after 4
weeks of use please visit your
dentist
_STOP AND ASK A DENTIST_
■ if problem the persists or worsens. Sensitive teeth may indicate a
serious problem that may need
prompt care by a dentist.
_KEEP OUT OF REACH OF CHILDREN_
If you accidentally swallowed more than used for brushing, seek
professional help or contact a Poison
Control Center immediately
DIRECTIONS
adults and children 12 years and older brush teeth for at least one
minute, preferably after each meal, or
at least twice a day, or as directed by your dentist. Be sure to brush
sensitive areas
children under 12 years of age consult a dentist or doctor.
_INACTIVE INGREDIENTS_
DC Yellow10, FDC Blue 1, flavor, glycerin, methylparaben, poly
ethylene glycol 1500, propylparaben,
silica, sodium benzoate, sodium carboxy methyl cellulose, sodium
lauryl sulfate, sodium
saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho
phosphate
PACKAGE LABEL
LUCKY SUPER SOFT SENSITIVE
sodium fluoride potassium nitrate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:20 276 -550
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO TASSIUM NITRATE (UNII: RU45X2JN0 Z) (NITRATE ION - UNII:T9 3E9 Y28
44)
POTASSIUM NITRATE
50 mg in 1 g
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8