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:

American Sales 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
AMERICAN SALES 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._
----------
DRUG FACTS
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
WARNINGS
for this product
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 INGREDIENT
water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium
chloride, sodium saccharin,
poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate,
disodium phosphate, calcium
disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate,
benzyl alcohol, green 3,
yellow 5
OTHER INFORMATION
• store at room temperature
DIS CLAIMER
This product is not manufactured or distributed by Chattem, Inc.,
distributor of Act Anticavity Fluoride
Rinse
SEALED WITH PRINTED NECKBAND FOR YOR PROTECTION
DISTRIBUTED BY:
American Sales Company
4201 Walden Avenue, Lancaster, NY 14086
403.002/AE rev2
PRINCIPAL DISPLAY PANEL
Compare to the Active Ingredients in ACT
CAREONE
ANTICAVITY
FLUORIDE
RINSE
MINT FLAVOR
Strong Cavity Protection
IMPORTANT: Read directions for proper use
18 FL OZ (53