CARDINAL HEALTH- sodium fluoride paste, dentifrice

Cardinal Health by

Drug Labeling and Warnings

Cardinal Health by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 200, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 REACH OF CHILDREN

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

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

INGREDIENTS AND APPEARANCE

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

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 SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-070-21	24 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2021	03/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/04/2021	03/31/2026

Labeler - Cardinal Health 200, LLC (961027315)