COLGATE SENSITIVE LASTING FRESH MINT BURST- potassium nitrate and sodium fluoride gel, 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:

Mission Hills S.A de C.V

INN (International Name):

POTASSIUM NITRATE

Composition:

POTASSIUM NITRATE 50 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact - helps protect against cavities

Authorization status:

OTC monograph not final

Summary of Product characteristics

COLGATE SENSITIVE LASTING FRESH MINT BURST- POTASSIUM NITRATE AND
SODIUM
FLUORIDE GEL, DENTIFRICE
MISSION HILLS S.A DE C.V
_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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COLGATE SENSITIVE LASTING FRESH MINT BURST GEL TOOTHPASTE
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Potassium nitrate 5%
Antisensitivity
Sodium fluoride 0.24% (0.14% w/v
fluoride ion)
Anticavity
US ES
builds increasing protection against painful sensitivity of the teeth
to cold, heat, acids, sweets or
contact
helps protect against cavities
WARNINGS
WHEN USING THIS PRODUCT, if pain/sensitivity still persists after 4
weeks of use, please visit your
dentist.
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.
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) or as recommended by a
dentist or physician. Make sure to brush all
sensitive areas of the teeth.
children under 12
years
consult a dentist or physician
INACTIVE INGREDIENTS
water, hydrated silica, glycerin, sorbitol, PEG-12, PVM/MA copolymer,
sodium lauryl sulfate, flavor,
poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum,
sodium saccharin, xanthan gum,
FD&C blue no. 1
QUES TIONS ?
®
1-800-468-6502
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022 U.S.A._
PRINCIPAL DISPLAY PANEL - 170 G TUBE CARTON
_MAXIMUM STRENGTH*_
_COLGATE_
_Toothpaste for Sensitive Teeth_
_and Cavity Protection_
_SENSITIVE_
_RELIEVES & FRESHENS_
_CLINICALLY PROVEN SENSITIVITY RELIEF_
_LONG-LASTING FRESHNESS_
_LASTING