AQUAFRESH ANTI-CAVITY sodium monofluorophosphate paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

SODIUM MONOFLUOROPHOSPHATE

Composition:

FLUORIDE ION 1.5 mg in 1 g

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

AQUAFRESH ANTI-CAVITY- SODIUM MONOFLUOROPHOSPHATE PASTE
AQUAFRESH CAVITY PROTECTION- SODIUM MONOFLUOROPHOSPHATE PASTE
AQUAFRESH EXTRA FRESH WHITENING- SODIUM MONOFLUOROPHOSPHATE PASTE
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
_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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DRUG FACTS
_ACTIVE INGREDIENT_
Sodium monofluorophosphate (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.
If you accidentally swallow more than used for brushing, get medical
help or contact the Poison
Control Center right away.
_DIRECTIONS_
•
•
_OTHER INFORMATION_
•
_INACTIVE INGREDIENTS (ANTI-CAVITY)_
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER
•
•
•
apply toothpaste onto a toothbrush
brush teeth thoroughly, preferably after each meal, 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 until good habits are established.
CHILDREN UNDER 2 YEARS consult a dentist or doctor
store below 30°C (86°F)
sorbitol, water, calcium carbonate, hydrated silica, PEG-8, sodium
lauryl sulfate, cellulose gum,
titanium dioxide, flavor, sodium bicarbonate, sodium saccharin, sodium
benzoate, calcium carrageenan,
FD&C blue #1 lake, D&C red #30
_INACTIVE INGREDIENT (CAVITY PROTECTION)_
sorbitol, water, calcium carbonate, hydrated silica, PEG-8, sodium
lauryl sulfate, cellulose gum,
titanium dioxide, flavor, sodium bicarbonate, sodium saccharin, sodium
benzoate, calcium carrageenan,
blue 1 lake, red 30 lake
_INACTIVE INGREDIENTS (CAVITY PROTECTION)_
Sorbitol, water, calcium carbonate, hydrated silica, glycerin, PEG-8