ANTICAVITY FLUORIDE- sodium fluoride mouthwash

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CVS Pharmacy

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 0.1 mg in 1 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity Aids in the prevention of dental cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

ANTICAVITY FLUORIDE- SODIUM FLUORIDE MOUTHWASH
CVS PHARMACY
_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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ANTICAVITY FLUORIDE MOUTHWASH
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium Fluoride 0.02% (0.01% w/v fluoride ion)
PURPOS E
Anticavity
US E
Aids in the prevention of dental cavities
WARNINGS
KEEP OUT OF REACH OF CHILDREN.
If more than used for rinsing is accidentally swallowed, get medical
help or contact a Poison Control
Center right away.
DIRECTIONS
Adults and children 6 years of age and older: Use twice a day after
brushing your teeth with a
toothpaste.
Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth
for 1 minute and then spit out.
Do not swallow the rinse.
Do not eat or drink for 30 minutes after rinsing.
Instruct children 12 years of age in good rinsing habits (to minimize
swallowing).
Supervise children as necessary until capable of using without
supervision.
Close cap fully after use, until the cap is felt to “click”, to
reengage the child resistant cap.
Children under 6 years of age: Consult a dentist or doctor
OTHER INFORMATION
Store at room temperature. Cold temperature may temporarily cloud this
product.
INACTIVE INGREDIENTS
water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin,
phosphoric acid, methylparaben,
poloxamer 407, propylparaben, disodium phosphate, blue 1
This rinse may cause temporary staining to the surface of teeth.
This is not harmful and adequate brushing may prevent its occurrence.
PRINCIPAL DISPLAY PANEL
Anticavity Fluoride
Mouthwash
Sodium Fluoride Oral Solution
Minty Fresh
33.8 FL OZ (1 L)
ANTICAVITY FLUORIDE
sodium fluoride mouthwash
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 8 42-429
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CVS Pharmacy
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLU