CARDINAL HEALTH- sodium fluoride paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 200, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity toothpaste Aids in the prevention of dental cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

CARDINAL HEALTH- SODIUM FLUORIDE PASTE, DENTIFRICE
CARDINAL HEALTH 200, LLC
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CARDINAL HEALTH TOOTHPASTE
_ACTIVE INGREDIENT_
Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)
_PURPOSE_
Anticavity toothpaste
_USES_
Aids in the prevention of dental cavities
_WARNINGS_
Keep out of the reach of children under 6yrs. of age. If you
accidentally swallow more
than used for brushing, seek medical help or contact a Poison Control
Center
immediately.
_DIRECTIONS:_
Adults and children 2 yrs. and older: brush teeth thoroughly after
meals or at least twice
a day or directed by a dentist or physician. Instruct children under
6yrs of age in good
brushing and rinsing habits (to minimize swallowing). Use a pea-size
amount for children
under 6. Supervise children as necessary until capable of using
without supervision.
Children under 2 yrs. of age: Consult a dentist or physician.
_INACTIVE INGREDIENTS:_
Sorbitol, Hydrated Silica, Water, Glycerin, PEG 12, Sodium Lauryl
Sulfate, Titanium
Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate,
Sodium
Saccharin, FD&C Blue #1
PRINCIPAL DISPLAY
anticavity toothpaste with fluoride
ADA Accepted American Dental Association
Cardinal Health™
net wt 0.85 oz (24 g)
NDC 63517-0702-1
NDC 63517-0702-1
REF OC-TPASTE
Distributed by: Cardinal Health, Waukegan, IL USA 60085
Rev.A 2020-11 • OC-TPASTE (F)
© 2020 Cardinal Health. All Rights Reserved.
cardinalhealth.com/symbolsglossary
CARDINAL HEALTH
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63517-070
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
FLUORIDE ION
0.15 g in 100 g
Cardinal Health 200, LLC
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
MINT (UNII: FV98Z8GITP)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SO