COLGATE SENSITIVE ENAMEL PROTECT- sodium fluoride and potassium nitrate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mission Hills S.A de C.V

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 1.1 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 ENAMEL PROTECT- SODIUM FLUORIDE AND POTASSIUM
NITRATE PASTE,
DENTIFRICE
MISSION HILLS S.A DE C.V
REFERENCE LABEL SET ID: EB309CFC-D8DF-4612-9C4E-622F0DA1A579
_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 ENAMEL PROTECT FLUORIDE TOOTHPASTE 4.0OZ
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Potassium nitrate 5%
Antisensitivity
Sodium fluoride 0.24% (0.15% 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, sorbitol, glycerin, hydrated silica, PEG-12, sodium lauryl
sulfate, flavor, cellulose gum,
tetrasodium pyrophosphate, sodium saccharin, xanthan gum, titanium
dioxide
QUESTIONS OR COMMENTS?
Call toll-free 1-800-468-6502
®
_Dist. by:_
_COLGATE-PALMOLIVE COMPANY_
_New York, NY 10022_
PRINCIPAL DISPLAY PANEL - 113 G TUBE CARTON
_COLGATE_
_ _
_TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION_
_MAXIMUM STRENGTH*_
_SENSITIVE_
_ENAMELPROTECT_
_CLINICALLY PROVEN_
_SENSITIVITY RELIEF_
NET WT 4