KIRKLAND SIGNATURE PRO-COMPLETE PLUS WHITENING sodium fluoride paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Costco Wholesale Corporation

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 1.5 mg in 1 g

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

KIRKLAND SIGNATURE PRO-COMPLETE PLUS WHITENING- SODIUM FLUORIDE PASTE
COSTCO WHOLESALE CORPORATION
_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_
Sodium fluoride (0.15% w/v fluoride ion)
_PURPOSE_
Anticavity
_USE_
aids in the prevention of dental cavities
_WARNINGS_
WHEN USING THIS PRODUCT,
if irritation occurs discontinue use
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. (FOR 63981-100)
If more than used for brushing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away.
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. (FOR 63981-101)
If more than used for brushing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away
_DIRECTIONS_
•
•
_OTHER INFORMATION_
•
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:
•
•
•
apply toothpaste onto a toothbrush
brush teeth thoroughly, preferably after each meal or at least twice a
day, and not more than
3 times a day, or as directed by a dentist or doctor. Minimize
swallowing. Spit out after
brushing.
to minimize swallowing for children under 6 years of age, use a
pea-sized amount and
supervise brushing and rinsing until good habits are established.
CHILDREN UNDER 2 YEARS consult a dentist or doctor.
store below 30°C (86°F)
_INACTIVE INGREDIENTS_
water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate,
PEG-8; sodium lauryl sulfate,
flavor, xanthan gum, titanium dioxide, sodium hydroxide, sodium
saccharin, sodium benzoate, blue 1
lake
_INACTIVE INGREDIENTS_
water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate,
PEG-8; sodium lauryl sulfate,
titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium
saccharin, blue 1
_QUESTIONS OR COMMENTS?_
call toll-free 1-888-511-0023
PRINCIPAL DISPLAY PANEL
NDC 63981-100-01
KIRKLAND _SIGNATURE_
FLUORIDE TOOTHPASTE
PRO COM