Cardinal Health Toothpaste

Cardinal Health Toothpaste
SPL v3
SPL
SPL Set ID b850287c-d71f-01a7-e053-2a95a90aa036
Route
ORAL
Published
Effective Date 2021-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Mint Polyethylene Glycol 600 Hydrated Silica Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Sodium Benzoate Saccharin Sodium Fd&c Blue No. 1 Sorbitol Glycerin Sodium Phosphate, Dibasic, Dihydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-01-04 Until 2026-03-31
Description

Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

Uses

Aids in the prevention of dental cavities

Section 50565-1

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.

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

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

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

Structured Label Content

Uses

Aids in the prevention of dental cavities

Section 50565-1 (50565-1)

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.

Purpose

Anticavity toothpaste

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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.390294 · Updated: 2026-03-14T23:03:06.131630