THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE- sodium fluoride rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Dr. Harold Katz, LLC

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

                                THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE- SODIUM FLUORIDE RINSE
DR. HAROLD KATZ, 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._
----------
THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE
_ACTIVE INGREDIENT_
Sodium Fluoride 0.05% (0.02%) w/v fluoride ion)
_PURPOSE_
Anticavity
_USE_
Aids in the prevention of dental cavities
_WARNINGS_
Keep Out Of Reach of Children.
_WARNINGS_
If more than used for rinsing is accidentally swallowed, get help or
contact a Poison
Control Center right away.
_DIRECTIONS_
• Adults and children 6 years of age and older: Use once a day after
brushing your teeth
with a
toothpaste. Vigorously swish 10 milliliters 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 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_
Do not use if safety seal is broken or missing
INACTIVE INGREDIENTS
Water, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric
Acid, Sucralose,
Sodium Citrate
THERABREATH KIDS ANTI CAVITY ORAL RINSE
THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE
sodium fluoride rinse
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72551-254
Dr. Harold Katz, LLC
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
FLUORIDE ION
0.0005 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
GRAPE (UNII: 6X543N684K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRAL
                                
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