SENSODYNE- potassium nitrate and sodium fluoride paste

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:

Haleon US Holdings LLC

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 the teeth to cold, heat, acids, sweets, or contact. - aids in the prevention of dental cavities.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SENSODYNE- POTASSIUM NITRATE AND SODIUM FLUORIDE PASTE
HALEON US HOLDINGS LLC
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DRUG FACTS
_ACTIVE INGREDIENTS_
Potassium nitrate 5%
Sodium fluoride 0.25% (0.16% w/v fluoride ion)
_PURPOSES_
Antihypersensitivity
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 ASK 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_
store below 30ºC (86ºF)
_INACTIVE INGREDIENTS_
water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate,
PEG-8, sodium lauryl
sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl
betaine, sodium
saccharin, blue 1
_QUESTIONS OR COMMENTS?_
1-866-844-2797
ADDITIONAL INFORMATION
ALWAYS FOLLOW THE LABEL
WHAT ARE SENSITIVE TEETH?
Lots of people have sensitive teeth. When enamel is worn away (through
eating
everyday acidic food or drinks) or gums recede, the dentin underneath
becomes
exposed. This can lead to tooth sensitivity, for example, with cold
and hot food and
drinks.
WHAT DOES SENSODYNE DO?
Sensodyne provides daily care for sensitive teeth* plus all the
benefits you would expect
from a daily fluoride toothpaste – strong teeth and freshness.
*with twice dai Ly brushing
24/7 SENS