KROGER COMPANY RADIANT WHITE- fluoride paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Kroger Company

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

aids in the prevention of dental caviites

Authorization status:

OTC monograph final

Summary of Product characteristics

KROGER COMPANY RADIANT WHITE- FLUORIDE PASTE, DENTIFRICE
KROGER 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 Monofluorophosphate 0.76% w/w (0.15% w/v fluoride
ion)..................................Purpose: Anticavity
USES
aids in the prevention of dental caviites
If more than used for brushing is accidentally swallowed, get medical
help or contact a
Poison Control Center right away.
Keep out of reach of children under 6 years of age.
DIRECTIONS
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: brush teeth thorughly
preferably
after each meal or at least twice a day, or as directed by a dentist
or doctor. Instruct
children under 6 years of age in good brushing and rinsing habits (to
avoid swallowing).
Supervise children as necessary until capable of using without
supervision.
OTHER INFORMATION
Store in a cool dry place. Keep tube capped when not in use.
INACTIVE INGREDIENTS
glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer,
hydrated silica,
hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate,
tetrasodium
pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated
hydroxytoluene, water
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: brush teeth throuoghly,
preferably
after every meal or at least twice a day, or as directed by a dentist
or doctor.
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KROGER COMPANY RADIANT WHITE
fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:30142-621
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION -
UNII:Q80VPU408O)
FLUORIDE ION
0.76 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)