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:

DZA Brands, LLC

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
DZA BRANDS, 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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ANTICAVITY FLUORIDE RINSE, MINT
213.002/213AE REV 2
ACTIVE INGREDIENT
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
PURPOSE
Anticavity rinse
USE
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
OTHER INFORMATION
store at room temperature
INACTIVE INGREDIENTS
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
DISCLAIMER
This product is not manufactured or distributed by Chattem, Inc.,
distributor of Act Anticavity Fluoride Rinse
ADVERSE REACTION
DISTRIBUTED BY: DZA Brands, LLC, 2110 Executive Drive, Salisbury NC
28147
For Product questions or concerns contact us at 1-866-322-2439
Please include UPC code number from package.
PRINCIPAL DISPLAY PANEL
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
IMPORTANT: READ DIRECTIONS FOR