ANTICAVITY FLUORIDE RINSE- 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:

The Great Atlantic + Pacific Tea Company

INN (International Name):

SODIUM FLUORIDE

Composition:

SODIUM FLUORIDE 0.05 kg in 100 L

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

aids in the prevention of dental cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

ANTICAVITY FLUORIDE RINSE- SODIUM FLUORIDE MOUTHWASH
THE GREAT ATLANTIC + PACIFIC TEA COMPANY
_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 RINSE
213
ACTIVE INGREDIENT
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
PURPOS E
Anticavity rinse
US E
aids in the prevention of dental cavities
WARNING
KEEP OUT OF REACH OF CHILDREN.
If more than used for rinsing is accidentally swallowed, seek
professional assistance or contact a
Poison Control Center immediately.
DIRECTIONS
• adults and children 6 years of age and older: use once a day after
brushing your teeth with a toothpaste
• remove cap
• pour 10 milliliters (10 mL mark on the inside of cap); do not fill
above the 10 mL mark
• vigorously swish 10 milliliters of rinse between your teeth for 1
minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to
minimize swallowing)
• supervise children as necessary until capable of using without
supervision
• children under 6 years of age: consult a dentist or doctor
INACTIVE INGREDIENTS
benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride,
disodium EDTA, disodium
phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407,
polysorbate 20, potassium
sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium
saccharin, sorbitol, water,
yellow 5
OTHER INFORMATION
• store at room temperature
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Distributed by: Onpoint, Inc
2 Paragon Drive
Montvale, NJ 07645
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTI